FDA.reportPublic FDA data

Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60

Product NDC
71679-312
11-digit product format
716790312
Labeler code
71679
Product ID
71679-312_56138f15-d8ff-eff5-e063-6394a90a326a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 500mg Pyrilamine Maleate 15mg and Caffeine 60mg Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Health Pharma USA LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-07
Substance
CAFFEINE; PYRILAMINE MALEATE
Active strength
60; 15 mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAFFEINE60 mg/1
PYRILAMINE MALEATE15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3G6A5W338EInternal UNII lookup
R35D29L3ZAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1597298Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
34eb8a9b-d0ee-13e8-e063-6294a90a2fefAvailable on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporationa63727c3-64d8-4ae9-8da3-974cae6beed22026-07-24WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCe4a2566e-48ec-4602-87e3-143398d15f332026-07-24WarningsExact identifier
application number: M013
infants fever reducer and pain relieverACETAMINOPHENRite Aid Corporation920e7055-7ed1-4db4-9215-f8933078bb7b2026-07-24WarningsExact identifier
application number: M013
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreensc6665c11-9a01-4472-a444-acadb1de0b692026-07-23WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC103d109d-f520-409c-8da2-eb6b0fbec8912026-07-22WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCce58105b-f010-47af-8f31-6dd4ce4e9cba2026-07-22WarningsExact identifier
application number: M013
GOOD SENSE INFANTS PAIN AND FEVERACETAMINOPHENL. Perrigo Companya7cc3964-e8fa-41da-89ca-b0d2aa80f2a72026-07-22WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENCardinal Health 107, LLC7562f4e4-54fa-488c-a199-48ad2632e2a12026-07-21WarningsExact identifier
application number: M013
MedlineACETAMINOPHENMedline Industries, LP4b1d7243-b943-4e2b-e063-6294a90a2c4e2026-07-20WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENLEADER/ Cardinal Health 110, Inc.7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d2026-07-16WarningsExact identifier
application number: M013
Rapidol 500 Extra StrengthACETAMINOPHENPharmadel LLC1d9fa7ec-a509-28b2-e063-6294a90a78312026-07-16WarningsExact identifier
application number: M013
equate pain reliefACETAMINOPHENWALMART INC.2f9b2550-5476-49ae-b741-54416a40bc292026-07-16WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLHyVee Inc4f45a750-1220-4a81-801e-bf08c9d117d62026-07-16WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENDr. Reddy's Laboratories Inc.9d34abc2-3a9a-b68f-80d4-4ede1eb1e45f2026-07-15WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENFamily Dollar, Inc.3f182571-3212-eb29-e063-6294a90a9fa02026-07-15WarningsExact identifier
application number: M013
AspirinASPIRINDOLGENCORP, LLC955484a6-2a7a-4b15-a9b4-e888ed5de04c2026-07-15WarningsExact identifier
application number: M013
AspirinASPIRINGeri-Care Pharmaceuticals, Corp58941782-362d-4436-b365-e909bdbd29a22026-07-15WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINMajor Pharmaceuticals44730dfb-5062-4015-924b-c30b6c2b19c22026-07-13WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINECardinal Health 110, LLC. DBA Leaderf1cd0d59-12a8-4ff2-942a-6faa6907ef052026-07-13WarningsExact identifier
application number: M013
AspirinASPIRINAmerisource Bergen2c5e80e8-a979-45fb-9297-8ff294280c252026-07-13WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71679-312-007167903120028500 TABLET, FILM COATED in 1 BOX (71679-312-00) 2024-03-07NoNoCurrent
71679-312-207167903122020 TABLET, FILM COATED in 1 BOTTLE (71679-312-20) 2024-03-07NoNoCurrent