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 23 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81 mgASPIRINHYVEE INC3e602287-565e-a5b9-e063-6294a90abc172026-01-13WarningsExact identifier
application number: M013
ASPIRIN DELAYED RELEASE 81MGASPIRIN DELAYED RELEASE 81MGFarmacias De Similares TX LLC3a8a3efc-f0b3-411c-e063-6394a90a84b72026-01-13WarningsExact identifier
application number: M013
Chewable Aspirin 81 mgASPIRINHYVEE INC459f749f-9d23-8752-e063-6394a90a8c812026-01-13WarningsExact identifier
application number: M013
ASPIRIN 325 mgASPIRINHYVEE INC459d01df-6ff6-cff6-e063-6394a90ab35c2026-01-13WarningsExact identifier
application number: M013
Pain Terminator Extra Strength Pain ReliefCAFFEINE, ACETAMINOPHEN, ASPIRINWildman Business Group8ffb02d9-92df-4d2f-a367-1c71490807fb2026-01-12WarningsExact identifier
application number: M013
Aspirin PacksASPIRINSina Health Inc2865a2c3-53fc-ab9a-e063-6394a90a14182026-01-12WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.64696f65-415e-4ce1-a5b3-70662fbcb0022026-01-12WarningsExact identifier
application number: M013
Aspirin enteric coated low doseASPIRINWalgreen Company186a6270-e3de-4499-88a4-5f723fee3e342026-01-12WarningsExact identifier
application number: M013
Tension HeadacheACETAMINOPHEN, CAFFEINECardinal Health 110, LLC. DBA Leader96684e3f-a13e-49c3-b437-d2627e528a2d2026-01-12WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINFamily Dollar Services Incd35d798e-76f1-454d-86f6-ad11c3bf17d82026-01-12WarningsExact identifier
application number: M013
Xpect AcetaminophenACETAMINOPHENCintas Corporationf4aed854-730e-493d-b523-122156e08dde2026-01-09WarningsExact identifier
application number: M013
AspirinASPIRININVAHEALTH INCe5e8a8d5-9174-7975-e053-2a95a90a9aa62026-01-08WarningsExact identifier
application number: M013
Xpect Cold ReliefACETAMINOPHEN GUAIFENESEIN PHENYLEPHRINE HCLCintas Corporation02391d55-32b2-4083-9315-98e9b3650c552026-01-08WarningsExact identifier
application number: M013
pain relief back and body EXTRA STRENGTHASPIRIN, CAFFEINERite Aid Corporationa71392c8-3f5b-4d00-baba-a4055ed68bc12026-01-07WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENL.N.K. International, Inc.8fed703a-9de2-4c76-a783-fcf004f9b8902026-01-07WarningsExact identifier
application number: M013
AspirinASPIRINAmerisource Bergenc3099892-a8cd-4574-a6f9-041e59e2feae2026-01-07WarningsExact identifier
application number: M013
Bactimicina Childrens Pain and FeverACETAMINOPHENDLC Laboratories, Inc.bdade270-d813-4178-b594-4951632b68392026-01-07WarningsExact identifier
application number: M013
Goodmeds Extra Strength Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.02c60967-46d7-49b7-82be-bc3c5fd364842026-01-06WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENARMY AND AIR FORCE EXCHANGE SERVICEa73f8217-9eae-4e2a-b29c-7de3861d0e372026-01-06WarningsExact identifier
application number: M013
Pain Relief Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporationf77f0120-4042-4b11-ba9c-cd35e1cd0bee2026-01-05WarningsExact 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