FDA.reportPublic FDA data

ACETAMINOPHEN PM

Product NDC
73057-352
11-digit product format
730570352
Labeler code
73057
Product ID
73057-352_2c27d537-a03c-3775-e063-6394a90ad003
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 500mg / Diphenhydramine HCl 25mg
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ulai Health LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-08
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73057-352-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73057-352-030efc9e666f02…f202fb6c5f17…

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
d4a568c9-a721-48d1-aebc-fc65444947ceAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73057-352-032022-01-31C16284748780-1d6a99b39-ebe0-a426-e053-dadaa90af4c2Drug Facts
73057-352-032022-01-28C16284748780-1d6a99b39-ebe0-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73057-352-03ACETAMINOPHEN PM24 in 1 BOTTLE, PLASTICTABLET, FILM COATED244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73057-352ACETAMINOPHEN PM (ACETAMINOPHEN 500MG / DIPHENHYDRAMINE HCL 25MG) TABLET, FILM COATED [ULAI HEALTH LLC]4Current NDC, Legacy NDC, 1 package rows20250122_d4a568c9-a721-48d1-aebc-fc65444947ce.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 75 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lil Drug Store Aspirin 325ASPIRINLil Drug Store Products, Incde59aae2-f794-4243-acc8-37a10e27abde2023-12-15WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHEN TABLET, EXTRA STRENGTHLil' Drug Store Products, Inc.f0fdab5a-9d07-57aa-e053-2a95a90adc7f2023-12-15WarningsExact identifier
application number: M013
BC CherryASPIRIN AND CAFFEINELil' Drug Store Products, Inc79ea721b-d656-44f7-9d13-390debee7be02023-12-15WarningsExact identifier
application number: M013
Alka-SeltzerBUFFERED ASPIRINLil' Drug Store Products, Inc.0c7a60e7-0bde-9aa2-e063-6294a90a32092023-12-14WarningsExact identifier
application number: M013
Circle K Aspirin 325ASPIRINLil Drug Store Products, Inc4cd306e3-2119-4272-9da4-a848fe2746fa2023-12-14WarningsExact identifier
application number: M013
Circle K Pain Reliever Extra StrengthACETAMINOPHENLil' Drug Store Products, Inc.f2359bc3-901f-4ecb-b402-cb2fe404a9352023-12-14WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENDISCOUNT DRUG MARTc55b8f9d-1396-43c0-acc9-5e3485eadb072023-12-08WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENDISCOUNT DRUG MART775519ad-5683-451f-9bfc-5fafc70c68ec2023-12-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREEN CO.c20c814b-35f5-4c46-e053-2a95a90a50f22023-12-08WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENBetter Living Brands LLCf9859be4-6d0b-2ab8-e053-6294a90aa8622023-12-06WarningsExact identifier
application number: M013
Aurophen Regular StrengthACETAMINOPHENKROGER COMPANYb9b7b849-c3b3-9af7-e053-2a95a90a00772023-12-06WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENKROGER COMPANYcf649478-57d2-cc88-e053-2a95a90ad1ba2023-12-06WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENKROGER COMPANYb9b6f878-1ec8-3dc0-e053-2995a90a54142023-12-06WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREEN CO.a48c522c-76c5-49f8-8c4d-3ee6b221e6f32023-12-06WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREEN CO.cc939a7c-ce56-5dd6-e053-2995a90aa8af2023-12-06WarningsExact identifier
application number: M013
Alka-Seltzer Original FlavorBUFFERED ASPIRIN, EFFERVESCENT TABLETLil' Drug Store Products, Inc.ea5df8be-a08c-5fa3-e053-2995a90a0bac2023-12-06WarningsExact identifier
application number: M013
RinglACETAMINOPHENSato Pharmaceutical Co., Ltd.ba5a0286-3e0f-4bef-96e5-29d92f51f4322023-12-06WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)41633554-474e-4d3c-9187-d90487d2ae8c2023-12-06WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFamily Dollar Stores, LLCf86dcbb8-debc-4bce-e053-6294a90a7a022023-12-05WarningsExact identifier
application number: M013
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRPharmadel LLC0a5fc0ef-ba34-bb0b-e063-6394a90af7d92023-12-01WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNd4a568c9-a721-48d1-aebc-fc65444947ce4
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDd4a568c9-a721-48d1-aebc-fc65444947ce4
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYd4a568c9-a721-48d1-aebc-fc65444947ce4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73057-352-037305703520324 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73057-352-03) 2019-07-080000-00-00NoNoCurrent