FDA.reportPublic FDA data

DRX CHOICE

Product NDC
68163-065
11-digit product format
681630065
Labeler code
68163
Product ID
68163-065_5fb4384d-b4aa-4b2d-a5d3-41ec75cb6384
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Raritan Pharmaceuticals Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-16
Substance
ACETAMINOPHEN
Active strength
325 mg/1
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
DRX CHOICE
Brand name suffix
Regular Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313782Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8bacb24a-24d0-4175-b3e0-05efb5f5d373Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68163-065-60DRX CHOICERegular Strength60 in 1 BOTTLETABLET, FILM COATED601

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 26 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Incf818417e-0b31-4fe7-8313-4160a00b248a2025-12-22WarningsExact identifier
application number: M013
CareALL AcetaminophenACETAMINOPHENNew World Imports, Incc4f82ed8-b82c-47bb-9ab9-108a13d29cf72025-12-22WarningsExact identifier
application number: M013
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Inc5103450a-3095-49cc-9823-4fb4c1d258ff2025-12-22WarningsExact identifier
application number: M013
CAREALL Non-Aspirin PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLNew World Imports, Inc499b2bf8-72fb-4500-b16e-517cab09a8ae2025-12-22WarningsExact identifier
application number: M013
CAREALL Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLNew World Imports, Inc933154b9-c9d6-4260-8775-1c83631c74e42025-12-22WarningsExact identifier
application number: M013
CAREALL Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLNew World Imports, Incc93aa5e4-3994-439f-8f14-4e81773ed4e22025-12-22WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLGranules USA, Inc.8c9f68e3-fedc-6457-e053-2995a90a045a2025-12-22WarningsExact identifier
application number: M013
AspirinASPIRINL.N.K. International, Inc.35005045-57b2-4ffe-ab70-22d570c1b1612025-12-22WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINENUVICARE LLCea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e2025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWalmart175495fd-c561-f813-e063-6294a90aac802025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALMART INC21b22e9f-b6d1-1819-e063-6294a90ae09c2025-12-19WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine HCLACETAMINOPHEN AND DIPHENHYDRAMINE HCLSAFEWAYf18c1aa2-5f8b-5458-e053-2995a90ab9472025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMeijer181b3148-fa33-c650-e063-6294a90a0de62025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTOPCO ASSOCIATES LLC1a00a49e-f9ff-b928-e063-6394a90a4cb52025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPUBLIX SUPERMARKETS, INC08f57305-0c4b-96b1-e063-6394a90a77df2025-12-19WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine HCLACETAMINOPHEN AND DIPHENHYDRAMINE HCLPUBLIX SUPERMARKETS, INC08f549cf-042a-7bf2-e063-6394a90a83ef2025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREEN CO.b8a855ae-c0a3-0b05-e053-2a95a90ac8a82025-12-19WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMarc Glassman, Inc.f708e1ec-cf2a-4e2b-851f-f6b703f359b22025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREEN CO.b375de90-25c7-aa55-e053-2995a90a3cf82025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTARGET CORPORATIONe64a3c32-5466-0662-e053-2a95a90ae9632025-12-19WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSN8bacb24a-24d0-4175-b3e0-05efb5f5d3731
313782acetaminophen 325 MG Oral TabletSCD8bacb24a-24d0-4175-b3e0-05efb5f5d3731
313782APAP 325 MG Oral TabletSY8bacb24a-24d0-4175-b3e0-05efb5f5d3731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68163-065-606816300656060 TABLET, FILM COATED in 1 BOTTLE (68163-065-60) 2025-05-16NoNoCurrent