Pain Reliever

Product NDC
68016-734
Requested package NDC
68016-734-01
11-digit product format
680160734
Labeler code
68016
Product ID
68016-734_24340ca1-73a1-ad18-e063-6394a90ab57c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CHAIN DRUG CONSORTIUM
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-29
Marketing end
2026-11-30
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
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
Pain Reliever

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 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
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5c1a3081-ae25-4895-bf76-ebcbb9fc8072Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-734-01Pain Reliever100 in 1 BOTTLE, PLASTICTABLET, COATED1005
68016-734-01Pain Reliever1 in 1 CARTONTABLET, COATED15
68016-734-22Pain Reliever225 in 1 BOTTLE, PLASTICTABLET, COATED2255
68016-734-50Pain Reliever50 in 1 BOTTLE, PLASTICTABLET, COATED505
68016-734-50Pain Reliever1 in 1 CARTONTABLET, COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-734PAIN RELIEVER (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM]5Current NDC, Legacy NDC, 5 package rows20241013_5c1a3081-ae25-4895-bf76-ebcbb9fc8072.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 54 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINProficient Rx LP9c186289-e309-45e8-8934-1d0eae0375c22024-12-01WarningsExact identifier
application number: M013
Childrens Chewable AcetaminophenACETAMINOPHENGERI-CARE PHARMACEUTICAL CORP22f63d62-c941-5b8f-e063-6394a90aeecd2024-11-28WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp7a7b6318-b7d6-31b1-e053-2991aa0abf252024-11-28WarningsExact identifier
application number: M013
Extra Strength Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLINGLES MARKETS, INC.27fd288e-c07a-617f-e063-6394a90a17a42024-11-28WarningsExact identifier
application number: M013
BAYER Aspirin Original, TRAVEL BASIXASPIRINLil' Drug Store Products, Inc.7f5d9ebe-8119-49a2-9380-eca18a5e5e852024-11-27WarningsExact identifier
application number: M013
EXCEDRIN MIGRAINEACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINEJones Healthcare Group - Packaging Services, Incc4168e4d-3dfc-4e51-a32e-14704cb59c662024-11-27WarningsExact identifier
application number: M013
TYLENOL Extra Strength / TYLENOL Precise Cooling Pain ReliefACETAMINOPHEN, LIDOCAINE, MENTHOLKenvue Brands LLC2611e984-0dd5-bda1-e063-6394a90a559a2024-11-26WarningsExact identifier
application number: M013
First Aid Only Extra-Strength Non-AspirinACETAMINOPHENAcme United Corporation6891d57a-10a6-53de-e053-2a91aa0ac7c22024-11-26WarningsExact identifier
application number: M013
Chewable AspirinASPIRINMARC GLASSMAN, INC.c8314910-71ff-5a55-e053-2995a90aafc72024-11-26WarningsExact identifier
application number: M013
AspirinASPIRINMarc Glassman, Inc.7990ca49-fb30-40fe-9ac4-48e89eac9bb22024-11-26WarningsExact identifier
application number: M013
Enteric Coated Aspirin Regular StrengthASPIRINSafeway96359eb6-62bc-4b13-960c-050af99a8c022024-11-26WarningsExact identifier
application number: M013
ASPIRIN Low DoseASPIRINMarc Glassman, Inc.3d519af3-9398-4439-8253-1e5d4612b8e32024-11-26WarningsExact identifier
application number: M013
ACETAMINOPHEN (RED)ACETAMINOPHENHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.06eabf4b-f8c0-439a-acf1-aa6e3075c7172024-11-25WarningsExact identifier
application number: M013
ACETAMINOPHEN (RED)ACETAMINOPHENHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltda352f588-4a70-42b2-8f9c-a73a0629517d2024-11-25WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.5c42dd28-820c-4cc5-9016-11ad5e5806162024-11-25WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWALMART INC.4518fe82-3ba8-4e9e-a036-776df7fb8d572024-11-21WarningsExact identifier
application number: M013
Family Wellness Pain RelieverASPIRINFAMILY WELLNESS SERVICES, INC.075e19f4-1a58-aedd-e063-6294a90af7082024-11-20WarningsExact identifier
application number: M013
MejoralitoACETAMINOPHENOPMX Chula Vistafd2ecde0-296e-060f-e053-6294a90afd982024-11-15WarningsExact identifier
application number: M013
Temp XACETAMINOPHENOPMX Chula Vistafd2edc32-0351-c991-e053-6294a90ab4ce2024-11-15WarningsExact identifier
application number: M013
CVS Health Extra Strength Antacid and Pain RelieverASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATECVS Pharmacyafe9e755-18ba-305f-e053-2995a90aa8d02024-11-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN5c1a3081-ae25-4895-bf76-ebcbb9fc80725
198440acetaminophen 500 MG Oral TabletSCD5c1a3081-ae25-4895-bf76-ebcbb9fc80725
198440APAP 500 MG Oral TabletSY5c1a3081-ae25-4895-bf76-ebcbb9fc80725

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-734-01680160734011 BOTTLE, PLASTIC in 1 CARTON (68016-734-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2021-03-292026-11-30NoNoCurrent