acetaminophen pm

Product NDC
41163-515
Requested package NDC
41163-515-01
11-digit product format
411630515
Labeler code
41163
Product ID
41163-515_24b11c3b-9c19-ff00-e063-6394a90adbed
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-09-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
acetaminophen pm
Brand name suffix
extra strength
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
f86a11af-6d3c-4638-870d-a663ddf49371Available on FDA.report

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
41163-515-01acetaminophen pmextra strength1 in 1 CARTONTABLET, COATED110
41163-515-01acetaminophen pmextra strength24 in 1 BOTTLE, PLASTICTABLET, COATED2410
41163-515-02acetaminophen pmextra strength50 in 1 BOTTLE, PLASTICTABLET, COATED5010
41163-515-02acetaminophen pmextra strength1 in 1 CARTONTABLET, COATED110
41163-515-03acetaminophen pmextra strength100 in 1 BOTTLE, PLASTICTABLET, COATED10010
41163-515-03acetaminophen pmextra strength1 in 1 CARTONTABLET, COATED110
41163-515-14acetaminophen pmextra strength200 in 1 BOTTLE, PLASTICTABLET, COATED20010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-515-01EA - Each41163-5155c6c8447-ffdb-4a36-ad82-f857e36fb2a512016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-515ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [UNITED NATURAL FOODS, INC. DBA UNFI]10Current NDC, Legacy NDC, 7 package rows20241019_f86a11af-6d3c-4638-870d-a663ddf49371.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 1 of 84 · 1,678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Acetaminophen 325 mgACETAMINOPHENNUVICARE LLC49a59b79-b8b4-4bf5-a403-0a14751efc552026-07-30WarningsExact identifier
application number: M013
KinderFarms Childrens Pain and FeverACETAMINOPHENKinderFarms, LLC4f86419a-b940-a9c6-e063-6394a90a6a2b2026-07-30WarningsExact identifier
application number: M013
KinderFarms Infants Pain and FeverACETAMINOPHENKinderFarms, LLC5468b149-8fac-8d6a-e063-6294a90a8c512026-07-29WarningsExact identifier
application number: M013
AspirinASPIRINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)3ba0a9f2-062a-401e-82eb-54383a8223662026-07-29WarningsExact identifier
application number: M013
Aspirin Low Dose ChewableASPIRINBetter Living Brands, LLC7afce7b4-c86a-43f7-83cf-15ebffba2f352026-07-28WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCf818996c-36d2-4d3d-af3e-39949157edb92026-07-28WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.03b871e8-3e14-4ed8-a978-45129255b2722026-07-27WarningsExact identifier
application number: M013
Pain Relief Acetaminophen PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporation17d27771-a112-474f-9a58-29af0d7e1af32026-07-27WarningsExact identifier
application number: M013
Children Pain Relief GummyACETAMINOPHEN CHILDREN GUMMYGummy USA5513db67-f023-7f47-e063-6294a90a27572026-07-24WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC2143cc16-86db-4060-96da-5c228ae9207b2026-07-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSoftgel Healthcare Pvt Ltd352bb451-ffdc-411a-e063-6294a90a8cf52026-07-24WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.fdb7331a-d029-8b2a-e053-6294a90adfcd2026-07-24WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLC5ada044e-50e8-4874-ac04-df5f1f9e735d2026-07-24WarningsExact identifier
application number: M013
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
Vicks PainQuil PAIN RELIEVERACETAMINOPHENThe Procter & Gamble Manufacturing Company0ad7b313-5d72-4cc0-97f0-1a30770350af2026-07-22WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNf86a11af-6d3c-4638-870d-a663ddf4937110
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDf86a11af-6d3c-4638-870d-a663ddf4937110
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYf86a11af-6d3c-4638-870d-a663ddf4937110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41163-515-01411630515011 BOTTLE, PLASTIC in 1 CARTON (41163-515-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2014-09-010000-00-00NoNoCurrent