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  7. Rulemaking History of General Labeling Requirements for OTC Drug Products
  1. Status of OTC Rulemakings

Rulemaking History of General Labeling Requirements for OTC Drug Products

OTC Drug Product Labeling Regulations (21 CFR part 201 subpart C):
Labeling Requirements for Over-the-Counter Drugs

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OTC Drug Product Labeling found on this page:

Labeling of Drug Products: Calcium, Magnesium and Potassium

Proposed RuleDateFR Citation
Proposed Rule: Requires labeling for oral OTC drug products4/22/199661FR17807
    Extension of Comment Period7/22/199661FR38047
    Correction8/19/199661FR42826
Final RuleDateFR Citation
Final Rule3/24/200469FR13725

Labeling of Drug Products: Exclusivity Policy

Advance Notice Of Proposed RulemakingDateFR Citation
Notice: Public hearing7/2/198247FR29002
Proposed RuleDateFR Citation
Proposed Rule: Allows alternative language for indications (exclusivity policy)4/22/198550FR15810
Proposed Rule: Miscellaneous additional interchangeable terms4/5/199358FR17553
Proposed Rule: Exclusivity policy applies to approved NDAs11/9/199358FR59622
Proposed Rule: Additional interchangeable terms "do not mix drugs"; requests comment on revising "do not use" warning8/3/199459FR39499
Proposed Rule: Additional interchangeable terms "do not use with"10/4/199560FR52058
Proposed Rule: Additional interchangeable terms "unless a doctor tells you"3/4/199661FR8450
Final RuleDateFR Citation
Final Rule: Allows alternative language for indications (exclusivity policy)5/1/198651FR16258
    Correction5/21/198651FR18580
    Correction3/13/198752FR7830
Final Rule: Miscellaneous additional interchangeable terms1/28/199459FR3998

Labeling of Drug Products: Phenylpropanolamine (PPA)

Proposed RulesDateFR Citation
Proposed Rule: Requires warning2/14/199661FR5912
Notice of Withdrawal12/12/200873FR75625

Labeling of Drug Products: Pregnancy Warning

Advance Notice Of Proposed RulemakingDateFR Citation
Proposed RuleDateFR Citation
Proposed Rule: Requires warning for systemically absorbed OTC drugs9/7/198247FR39470
    Correction9/21/198247FR41580
    Reopening of Administrative Record: Requests comment on requiring warning for all OTC drugs11/30/198348FR54077
Proposed Rule: Specific warning for oral and rectal aspirin- containing OTC products11/16/198853FR46204
Final RuleDateFR Citation
Final Rule12/3/198247FR54750
    Notice: Exemptions to 12/3/1982 final rule8/31/198348FR39452
Final Rule: Specific warning for oral and rectal aspirin-containing OTC products7/5/199055FR27776

Labeling of Drug Products: Sodium Labeling

Proposed RuleDateFR Citation
Proposed Rule: Requires labeling for oral OTC drugs4/25/199156FR19222
    Correction5/22/199156FR23619
    Extension of Comment Period6/12/199156FR26946
Proposed Rule: Requires labeling for rectal OTC drugs3/24/200469FR13765
Final RuleDateFR Citation
Final Rule: Requires labeling for oral OTC drugs4/22/199561FR17798
    Extension of Comment Period7/22/199661FR38046
   Correction3/21/199762FR13733
    Partial Delay of Effective Date: Delays to coincide with calcium, magnesium, potassium final rule4/24/199762FR19923
   Technical Amendment: Termination of delay of effective date3/24/200469FR13717
Final Rule Requires labeling for rectal OTC drugs11/29/200469FR69278

Labeling of Drug Products: Drug Facts Format

Advance Notice Of Proposed RulemakingDateFR Citation
Notice: Request for comment on print size requirements3/6/199156FR9363
   Extension of Comment Period4/9/199156FR14384
Notice: Hearing on OTC labeling8/16/199560FR42578
Proposed RuleDateFR Citation
Proposed Rule2/27/199762FR9024
   Extension of Comment Period6/19/199762FR33379
Notice: Availability of Study Data and Reopening of Comment Period12/30/199762FR67770
Notice: Availability of Study Data and Reopening of Comment Period2/13/199863FR7331
Final RuleDateFR Citation
Final Rule3/17/199964FR13254
   Correction4/15/199964FR18571
    Technical Amendment: Clarifies regulations1/3/200065FR7
   Partial Extension of Compliance Dates6/20/200065FR38191
   Partial Delay of Compliance Dates: Convenience size OTC drugs4/5/200267FR16304
    Delay of Implementation: OTC sunscreen drugs9/3/200469FR53801
Notice: Draft Guidance on Drug Facts12/1/199964FR67291
Notice: Draft Guidance on submitting exemptions to Drug Facts12/19/200065FR79371
Notice: Draft Guidance on Drug Facts
12/9/200469FR71420
Notice: Draft Guidance on Drug Facts; Q and A
 Draft Guidance

 

1/13/200570FR2415
Notice: Guidance on Drug Facts; Q and A
 Guidance

 

1/5/200974FR303
PRA 60-Day Notice: Extension of Collection Activity1/4/200570FR362
PRA 30-Day Notice: Extension of Collection Activity3/29/200570FR15864
PRA 60-day Notice: Reinstatement of Collection Activity6/3/201075FR31448
PRA 30-day Notice: Reinstatement of Collection Activity8/13/201075FR49495
OMB Approval Notice: Reinstatement of Collection Activity2/16/201176FR9022

Labeling of Drug Products: Statement of Identity

Proposed RuleDate FR Citation
Proposed Rule: Requires for single actives and combinations as stated in OTC drug monographs4/17/198651FR13023
    Extension of Comment Period6/3/198651FR19853

Labeling of Drug Products: Adverse Event Reporting

Proposed RuleDateFR Citation
Proposed Rule: Requires toll-free number for reporting adverse events4/22/200469FR21778
Final RuleDateFR Citation
Interim Final Rule: Requires toll-free number for reporting adverse events1/3/200873FR402
Final Rule: Requires toll-free number for reporting adverse events10/28/200873FR63886
Notice: Draft Guidance on Labeling: Q and A12/11/200873FR75436
Notice: Guidance on Labeling: Q and A
Guidance
9/1/200974FR45222

Labeling of Drug Products: Convenience-Size

Proposed RuleDateFR Citation
Proposed Rule: Defines "convenience-size" & allows alternative labeling12/12/200671FR74474

Labeling of Drug Products: Label Comprehension Studies

Proposed RuleDate FR Citation
Notice: Label Comprehension Studies
Draft Guidance
5/1/200974FR20322
Notice of Availability: Final Guidance8/3/201075FR45641

Labeling of Drug Products: Dosage Delivery Devices

Proposed RuleDateFR Citation
Notice: Draft Guidance on Dosage Delivery Devices for Liquid Products
Draft Guidance
11/5/200974FR57319