Drugs

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

 

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