FDA.reportPublic FDA data

Acetaminophen

Product NDC
0363-9605
11-digit product format
003639605
Labeler code
0363
Product ID
0363-9605_0bfa94dc-1f27-efa5-e063-6394a90aa629
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
WALGREEN CO.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-05
Substance
ACETAMINOPHEN
Active strength
160 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 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
313820Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c20c814b-35f5-4c46-e053-2a95a90a50f2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9605-07Acetaminophen6 in 1 BLISTER PACKTABLET66
0363-9605-07Acetaminophen4 in 1 CARTONTABLET46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9605ACETAMINOPHEN TABLET [WALGREEN CO.]6Current NDC, Legacy NDC, 2 package rows20231208_c20c814b-35f5-4c46-e053-2a95a90a50f2.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 55 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreens667418fc-a3ab-cbc7-e053-2a91aa0a20232024-11-13WarningsExact identifier
application number: M013
Up and Up Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATETarget Corporationa72eef45-b985-638a-e053-2995a90aa20a2024-11-13WarningsExact identifier
application number: M013
Signature Care Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATESafeway, Inc6e120024-475a-73af-e053-2a91aa0a42a62024-11-13Warnings, Adverse reactionsExact identifier
application number: M013
Kroger Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEKroger Company6d858b0e-a3c8-2686-e053-2991aa0acc062024-11-13WarningsExact identifier
application number: M013
TopCare Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATETopco Associates LLC639f9d57-f26a-708a-e053-2a91aa0a69622024-11-13Warnings, Adverse reactionsExact identifier
application number: M013
Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEH. E. Butt Grocery Company6418cde9-607b-4ca1-e053-2991aa0a91702024-11-13WarningsExact identifier
application number: M013
Bromo SeltzerASPIRIN, SODIUM BICARBONATE, CITRIC ACIDTower Laboratories Ltd8ff88ee1-e33e-4051-992f-24e2720c48ce2024-11-13WarningsExact identifier
application number: M013
Care One Original Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEFoodhold U.S.A.8f662c51-d2fa-6458-e053-2995a90ac6fd2024-11-13WarningsExact identifier
application number: M013
Top Value Effervescent Pain ReliefAPIRIN, CITRIC ACID, SODIUM BICARBONATETower Laboratories Ltd43c7f435-735c-3fab-e054-00144ff88e882024-11-13Warnings, Adverse reactionsExact identifier
application number: M013
DG Health Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDOLGENCORP, INC8f1343d5-2884-3a14-e053-2a95a90a2f902024-11-13WarningsExact identifier
application number: M013
Good Sense Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEGood Sensecd25b0c3-0134-beef-e053-2a95a90a092b2024-11-13WarningsExact identifier
application number: M013
Drug Mart Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDiscount Drug Mart, Inc8bc65603-1dbf-30ab-e053-2995a90a7c152024-11-13WarningsExact identifier
application number: M013
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Company8aab905b-5fe7-dddb-e053-2995a90a6c6f2024-11-13WarningsExact identifier
application number: M013
Publix Fast Relief EffervescentASPIRIN, CITRIC ACID, SODIUM BICARBONATEPublix Super Markets Inc.73051f16-2569-7394-e053-2991aa0a53592024-11-13WarningsExact identifier
application number: M013
Quality Choice Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association70d265de-ff94-e0e4-e053-2a91aa0a962a2024-11-13WarningsExact identifier
application number: M013
Quality Choice Extra Strength Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association9f7d0c96-a561-a8a0-e053-2995a90a250b2024-11-13WarningsExact identifier
application number: M013
WinCo Foods Effervescent Antacid and Pain ReliefASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLETWinCo Foods, LLC0c8a755a-089f-477f-97e9-0dd6fdfbe99d2024-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENKroger Company8fb19444-f0e0-4d26-81e8-6a4b835056d82024-11-12WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWALMART INC.59d01f72-4575-48e2-b914-b6a6456ca7d22024-11-11WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENKroger Companyd181560c-1c39-4f2e-8a17-996224ca040f2024-11-09WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313820acetaminophen 160 MG Chewable TabletPSNc20c814b-35f5-4c46-e053-2a95a90a50f26
313820acetaminophen 160 MG Chewable TabletSCDc20c814b-35f5-4c46-e053-2a95a90a50f26
313820APAP 160 MG Chewable TabletSYc20c814b-35f5-4c46-e053-2a95a90a50f26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9605-07003639605074 BLISTER PACK in 1 CARTON (0363-9605-07) / 6 TABLET in 1 BLISTER PACK4 blister pack2021-07-050000-00-00NoNoCurrent