FDA.reportPublic FDA data

ACETAMINOPHEN PM

Product NDC
72476-171
11-digit product format
724760171
Labeler code
72476
Product ID
72476-171_1adb0e1c-a806-ed20-e063-6294a90a46ee
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
RETAIL BUSINESS SERVICES , LLC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-01
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500; 25 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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 PM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1092189Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
093199be-e92a-6f60-e063-6294a90a8533Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-171-01ACETAMINOPHEN PM1 in 1 CARTONTABLET, COATED12
72476-171-01ACETAMINOPHEN PM20 in 1 BOTTLE, PLASTICTABLET, COATED202
72476-171-03ACETAMINOPHEN PM1 in 1 CARTONTABLET, COATED12
72476-171-03ACETAMINOPHEN PM80 in 1 BOTTLE, PLASTICTABLET, COATED802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-171ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [RETAIL BUSINESS SERVICES , LLC.]2Current NDC, 4 package rows20240616_093199be-e92a-6f60-e063-6294a90a8533.zip

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 72 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Tension HeadacheACETAMINOPHEN, CAFFEINEHaleon US Holdings LLC12c074d1-81ac-47d2-8747-b018cda0058a2024-03-13WarningsExact identifier
application number: M013
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEStrive Pharmaceuticals Inc.78c12459-3b27-4ed0-943d-520794eb438d2024-03-07WarningsExact identifier
application number: M013
Pain Reliever fever Reducer Extra StrengthACETAMINOPHENCVS Pharmacy7b5263ad-01b7-4fc5-9384-4da8efe89e352024-03-06WarningsExact identifier
application number: M013
Excedrin Extra Strength GeltabsACETAMINOPHEN, ASPRIN, CAFFEINEHaleon US Holdings LLC11a8439b-0159-4351-b0f5-fe7fad6a33c02024-03-05WarningsExact identifier
application number: M013
Winco Foods Effervescent Pain ReliefASPIRINWinco Foods, LLC128afdd7-a9d1-8957-e063-6294a90af5692024-03-05WarningsExact identifier
application number: M013
Aspirin Low Dose Safety CoatedASPIRINCare One (Retail Business Services, LLC.)6659e103-fa03-4de0-af42-d2fbd548a87c2024-03-05WarningsExact identifier
application number: M013
Dolex Children Pain and FeverACETAMINOPHENPharmadel LLCf9158463-aeb1-5de0-e053-6294a90a748b2024-03-04WarningsExact identifier
application number: M013
SEDALMEX FORTEACETAMINOPHEN, ASPIRIN, CAFFEINEBelmora LLC33b3508e-4caa-4d05-9b15-cb82a2ee2d4d2024-02-28WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAMERISOURCE BERGEN2b923a97-836c-4dac-a8c0-3047a35fb62e2024-02-23WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBJWC (Berkley & Jensen / BJ's)b20a08f3-c9c0-4bd9-8ce0-acb932b5bb862024-02-22WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepack31a41976-7f65-42d7-acf5-de9c2c5ca58e2024-02-20WarningsExact identifier
application number: M013
Publix Fast Relief Effervescent - Original FlavorASPIRINPUBLIX SUPER MARKETS INC.0a342f72-45fd-3e12-e063-6394a90ae33e2024-02-16WarningsExact identifier
application number: M013
Equaline Effervescent Pain RelieverASPIRINUNITED NATURAL FOODS, INC. DBA UNFI0761299a-e913-7665-e063-6394a90a60032024-02-16WarningsExact identifier
application number: M013
TopCare Effervescent Pain ReliefASPIRINTOPCO ASSOCIATES LLC075f36e1-110c-e839-e063-6294a90a89d72024-02-16WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.115d0b4f-6f0f-79a9-e063-6394a90ab18a2024-02-14WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLCe1799765-c247-42b4-ad6a-8ba7d136abf22024-02-06WarningsExact identifier
application number: M013
Panadol Cold and Flu NonDrowsyACETAMINOPHEN AND PHENYLEPRINE HCLHaleon US Holdings LLCf626ab17-01c9-4493-ba9e-0c8c111463842024-02-06WarningsExact identifier
application number: M013
PANADOL ExtraACETAMINOPHEN AND CAFFEINEHaleon US Holdings LLCe5c2d88a-d903-4ca0-b895-f27e791dfc4e2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLCb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLC9d384e88-5c11-4600-ac6c-a383715701382024-02-06WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN093199be-e92a-6f60-e063-6294a90a85332
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD093199be-e92a-6f60-e063-6294a90a85332
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY093199be-e92a-6f60-e063-6294a90a85332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72476-171-01724760171011 BOTTLE, PLASTIC in 1 CARTON (72476-171-01) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC2024-03-01NoNoCurrent
72476-171-03724760171031 BOTTLE, PLASTIC in 1 CARTON (72476-171-03) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC2024-03-01NoNoCurrent