acetaminophen pm

Product NDC
68196-556
11-digit product format
681960556
Labeler code
68196
Product ID
68196-556_2b701514-75fd-46d0-95c2-0adc9e9a383f
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Sam's West Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-12-17
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
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 pm
Brand name suffix
extra strength
Listing expiration
2027-12-31

Active Ingredients#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-556-54acetaminophen pmextra strength375 in 1 BOTTLE, PLASTICTABLET, COATED37514

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]1
GELATININACTIVE INGREDIENT2G86QN327LACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-556ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [SAM'S WEST INC]13Current NDC, Legacy NDC, 1 package rows20240829_cff9a730-2241-4e4c-bf6b-a2fa895e2417.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 33 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRA STRENGTH PAIN RELIEVERACETAMINOPHEN, ASPIRIN AND CAFFEINEGeri-Care Pharmaceutical Corpb670a898-2360-76e2-e053-2a95a90a33802025-11-17WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.ec902e52-0f48-4a61-b67d-17e1c14616192025-11-15WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENL.N.K. International, Inc.72babe91-2586-4f05-ae90-6debfd23aa5d2025-11-15WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINStrategic Sourcing Services LLC3c7883da-6f51-4716-b012-0e33d239a60e2025-11-15WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINSam's West Inc3b84746f-05ab-4f88-b9ae-efb8c5dfc2332025-11-15WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENWalgreen Companya482e715-bec0-44a4-bb0e-ea5f5fda558e2025-11-15WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLARMY AND AIR FORCE EXCHANGE SERVICEf1157dbc-d86c-4554-954c-60a74674ff6b2025-11-15WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINENuCare Pharmaceuticals,Inc.437e4fd9-c7d9-77d6-e063-6294a90a22b72025-11-13WarningsExact identifier
application number: M013
Good Sense Pain ReliefACETAMINOPHENL. Perrigo Company7f78028a-484b-48b3-a37a-1e0b055bbefc2025-11-13WarningsExact identifier
application number: M013
OneSsip AcetaminophenACETAMINOPHENMEDWISE LIFESCIENCES INC.3f88de0f-6cf6-3580-e063-6294a90abcb42025-11-12WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDENavajo Manufacturing Company Inc.435b1a31-353d-af20-e063-6294a90aa9072025-11-11WarningsExact identifier
application number: M013
Good Neighbor Pharmacy Pain ReliefACETAMINOPHENAmerisource Bergen4b829607-f5fb-427f-83b5-5b6b9c44ebeb2025-11-11WarningsExact identifier
application number: M013
Pamprin Max Menstrual Pain ReliefACETAMINOPHEN AND ASPIRIN AND CAFFEINEFocus Consumer Healthcare, LLC5bd4b935-f003-7df8-e053-2a91aa0a5d792025-11-10WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENShield Pharmaceuticals Corp61e50135-a7c2-4a86-8a1a-d47b41d3f9d12025-11-07WarningsExact identifier
application number: M013
Childrens ChewablesACETAMINOPHENStrategic Sourcing Services LLCaf2cbbaf-9b73-440a-bc88-a790cafccc6b2025-11-07WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINL.N.K. International, Inc.39e142a7-8590-4e1e-8319-6904fb57cc8a2025-11-06WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC42321456-d7dd-3b51-e063-6394a90ac2922025-11-05WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENFamily Dollar Services Inc76058eb3-2d3f-4414-87df-7167cd27d26b2025-11-05WarningsExact identifier
application number: M013
Children Pain and Fever ReliverACETAMINOPHENTarget Corporation1116f808-f61e-47ec-b0d0-d4be5aa905be2025-11-04WarningsExact identifier
application number: M013
Pain Reliever Dye FreeACETAMINOPHENTIME CAP LABORATORIES, INC.42c4f0b2-6483-0f3c-e063-6294a90a140f2025-11-04WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNcff9a730-2241-4e4c-bf6b-a2fa895e241714
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDcff9a730-2241-4e4c-bf6b-a2fa895e241714
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYcff9a730-2241-4e4c-bf6b-a2fa895e241714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68196-556-5468196055654375 TABLET, COATED in 1 BOTTLE, PLASTIC (68196-556-54) 2007-12-170000-00-00NoNoCurrent