FDA.reportPublic FDA data

Pain Reliever

Product NDC
68016-734
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68016-73468016-734-22DDiscontinued by firm2026-10-16
excluded packagepackage68016-73468016-734-50DDiscontinued by firm2026-10-16

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 47 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOOD REMEDIES Extra Strength Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d642d8e-c154-a970-e063-6294a90a03bf2025-03-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac42025-03-07WarningsExact identifier
application number: M013
Redicare Non-Aspirin 500mgREDICARE NON-ASPIRIN, ACETAMINOPHEN 500MGRedicare LLC2f229898-1777-732c-e063-6394a90a76bc2025-03-04Warnings, Adverse reactionsExact identifier
application number: M013
Major Extra Strength Acetaminophen LiquidACETAMINOPHENMajor Pharmaceuticals2f3af4dd-45d5-87b4-e063-6294a90ab3cc2025-02-28WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINNCS HealthCare of KY, LLC dba Vangard Labsed9a71d6-a56e-416a-bb89-6d41307efc5a2025-02-27WarningsExact identifier
application number: M013
AspirinASPIRINPD-Rx Pharmaceuticals, Inc.77429b7f-78e4-42c0-8679-ae8da17488482025-02-26WarningsExact identifier
application number: M013
AeroTab Non-AspirinACETAMINOPHEN 500MG ESAero Healthcarefaa3a4ef-3c70-06ca-e053-6394a90a512d2025-02-26WarningsExact identifier
application number: M013
Bufferin Regular Strength Pain ReliefASPIRINGenomma Lab USA3543b2bf-1062-468a-a5dc-eabb2408af8c2025-02-25WarningsExact identifier
application number: M013
Calmour Childrens Acetaminophen Strips ChewableACETAMINOPHEN ORAL CHEWABLE 80 MGCalmourae47b027-4f29-45bb-a8bd-8129789328352025-02-22WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLCf9de7c2f-016b-4f40-8b5e-141ad194be972025-02-20WarningsExact identifier
application number: M013
Genexa Acetaminophen PM Extra StrengthACETAMINOPHENGenexa Inc.d82cf6f3-a291-ca2b-e053-2a95a90a6de12025-02-20WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENAdvagen Pharma Limited8b9456c9-a56b-4748-adb8-c66d6bf072e82025-02-19WarningsExact identifier
application number: M013
Genexa Childrens AcetaminophenACETAMINOPHENGenexa Inc.d89fd9d8-d88e-3968-e053-2a95a90afc5f2025-02-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.debfa787-7a48-48b5-94b0-6128205240322025-02-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.b16e5dcf-b290-4ff2-a150-4b875647ec9a2025-02-19WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCbb6533e5-e6a9-488c-b8ab-a6a06e87ede92025-02-18WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCc830320e-72ba-48ff-a4cd-250ac5650bf02025-02-18WarningsExact identifier
application number: M013
Aspirina CapletsASPIRINBayer HealthCare LLC.2e6f5ba8-8e8b-6059-e063-6394a90adcd52025-02-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.da7d95af-6583-429d-8d04-e0424f32e9ad2025-02-17WarningsExact identifier
application number: M013
GOODYS Mental AlertASPIRIN AND CAFFEINEMedtech Products Inc.31ef6d07-d314-4d09-abcd-389ba66cbcc52025-02-17WarningsExact 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
68016-734-2268016073422225 TABLET, COATED in 1 BOTTLE, PLASTIC (68016-734-22) 2021-03-290000-00-00NoNoCurrent
68016-734-50680160734501 BOTTLE, PLASTIC in 1 CARTON (68016-734-50) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC2021-03-290000-00-00NoNoCurrent