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 43 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate childrens pain and feverACETAMINOPHENWal-Mart Stores Incf15037a5-4e43-4dd6-93b8-b37a1cc22cd62025-07-07WarningsExact identifier
application number: M013
Childrens Acetaminophen Oral Liquid Grape FlavorACETAMINOPHENAARNA USA INC.39347f5d-2d3c-0c23-e063-6294a90a3a462025-07-05WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Incbe841460-98b4-4448-a494-09ff161fd1312025-07-02WarningsExact identifier
application number: M013
Adult Low Dose AspirinASPIRINAdvanced Rx LLCad0d6a5c-eee9-406c-8d7f-1df9b45f53402025-07-02WarningsExact identifier
application number: M013
EXTRA STRENGHT HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINELil' Drug Store Products, Inc.ec04eb5d-96c0-ddb4-e053-2a95a90a4a922025-07-02WarningsExact identifier
application number: M013
Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo packDEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATEGenexa Inc.18835205-a9e3-15c2-e063-6394a90a81072025-07-02WarningsExact identifier
application number: M013
FeverAllACETAMINOPHENSun Pharmaceutical Industries, Inc.8970b91b-5f3c-4764-9e23-25dcb398d0a72025-07-02WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Inc11c9712d-c3b2-49cd-9c2b-0f57190c954e2025-07-02WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINUnited Natural Foods, Inc. dba UNFI979973c1-661a-4384-8b92-fd901ebde5582025-07-01WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENCVS Pharmacyf6bbce1c-9790-4ca4-847f-579c594ffe0b2025-07-01WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS07d2e322-2465-79e5-e063-6294a90a5ea42025-06-30WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART66c0cf26-357b-4722-9100-3b86d507a8cd2025-06-30WarningsExact identifier
application number: M013
ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKroger Companybc019c9e-8fac-5fd3-e053-2a95a90a7ccd2025-06-25WarningsExact identifier
application number: M013
ACETAMINOPHEN Extra StrengthACETAMINOPHENTIME CAP LABS INCfd24d0e0-4f36-42d3-9149-2fb9576903052025-06-25WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINATLANTIC BIOLOGICALS CORP.024c5054-959f-4ea5-a71f-c0e16cc4b90c2025-06-24WarningsExact identifier
application number: M013
CHILDRENS ACETAMINOPHENCHILDRENS ACETAMINOPHEN ORALAARNA USA INC.38070d15-2678-4e59-e063-6294a90ab6902025-06-20WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENMorning Star OTC8502ea21-937d-4b33-a3e0-ffab5dc38cd82025-06-19WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEMorning Star OTC6cd07a01-7034-4994-bbd3-bedcdf7d5b832025-06-19WarningsExact identifier
application number: M013
DRX CHOICE Tension HeadacheACETAMINOPHEN, CAFFEINERaritan Pharmaceuticals Inc.8a5cb38b-669d-4177-b33b-d73c7ef48d182025-06-13WarningsExact identifier
application number: M013
good sense childrens pain and feverACETAMINOPHENNuCare Pharmaceuticals,Inc.3777f4fb-d279-199d-e063-6394a90acf362025-06-13WarningsExact 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