FDA.reportPublic FDA data

Acetaminophen

Product NDC
30142-507
11-digit product format
301420507
Labeler code
30142
Product ID
30142-507_4244c2ed-f273-4caa-a411-3f40e32a2f25
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kroger Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-08-18
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage30142-50730142-507-62DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
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
5bfd9841-c781-43be-b823-d334893ae6edAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-507-62Acetaminophen24 in 1 BOTTLETABLET, FILM COATED246
30142-507-62Acetaminophen1 in 1 CARTONTABLET, FILM COATED16
30142-507-78Acetaminophen1 in 1 CARTONTABLET, FILM COATED16
30142-507-78Acetaminophen100 in 1 BOTTLETABLET, FILM COATED1006
30142-507-83Acetaminophen1 in 1 CARTONTABLET, FILM COATED16
30142-507-83Acetaminophen225 in 1 BOTTLETABLET, FILM COATED2256

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN CAPSULE, COATED [KROGER COMPANY]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN CAPSULE, COATED [KROGER COMPANY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN CAPSULE, COATED [KROGER COMPANY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN CAPSULE, COATED [KROGER COMPANY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN CAPSULE, COATED [KROGER COMPANY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN CAPSULE, COATED [KROGER COMPANY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HACETAMINOPHEN CAPSULE, COATED [KROGER COMPANY]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN CAPSULE, COATED [KROGER COMPANY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN CAPSULE, COATED [KROGER COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-507ACETAMINOPHEN TABLET, FILM COATED [KROGER COMPANY]6Current NDC, Legacy NDC, 6 package rows20241027_5bfd9841-c781-43be-b823-d334893ae6ed.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 3 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Headache Formula Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEARMY AND AIR FORCE EXCHANGE SERVICEee8d0961-7572-471f-8c96-b4c0bd354de22026-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRugby Laboratories76f10ee2-1d6a-097c-e053-2991aa0af5262026-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMajor Pharmaceuticals780aad35-d0f1-44b1-e053-2991aa0af9a72026-08-18WarningsExact identifier
application number: M013
CHILDRENS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC5eacbc4f-d20a-4c22-9680-4a648e24de432026-08-18WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENWinCo Foods, LLC15921c3f-e8d4-4794-983f-63bb926f6f862026-08-15WarningsExact identifier
application number: M013
Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACYe4cbfb06-d826-4d08-95d6-60305c4176252026-08-14WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENCVS Pharmacy,Inc.3738d35c-1e83-40df-9292-c54e6b2c83532026-08-14WarningsExact identifier
application number: M013
CVS Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACY22a48a33-995b-481e-9e4e-1ad7ec346f442026-08-14WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECVS Pharmacy31ccc867-ca83-70a9-f3d5-5644030047b82026-08-13WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENTopco Associates, LLC8b9e90da-98e2-4d8d-bf6e-54b0a8f8d1012026-08-12WarningsExact identifier
application number: M013
Aspirin 81mgASPIRINHARRIS TEETER54e69d5a-55d7-4ebe-8494-0be93613f1e22026-08-12WarningsExact identifier
application number: M013
Chewable AspirinASPIRINHARRIS TEETERc6a28c83-60c9-3304-e053-2a95a90aa06c2026-08-12WarningsExact identifier
application number: M013
ASPIRINASPIRINHARRIS TEETER93cbd3cb-1072-89e6-e053-2995a90a2f152026-08-12WarningsExact identifier
application number: M013
Adult Chewable AspirinASPIRINHARRIS TEETERc6a28617-1769-7a7d-e053-2995a90a1ea02026-08-12WarningsExact identifier
application number: M013
Gencare- Pain Relief AcetaminophenACETAMINOPHENPioneer Life Sciences, LLC2111c91b-2fd7-4ab3-946a-d4e0cf46399a2026-08-12WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENSalado Sales, Inc.1dbd8480-5cb4-4577-9091-b2a2add4f1af2026-08-12WarningsExact identifier
application number: M013
pain relief childrensACETAMINOPHENRite Aid Corporation29ecdd2d-aeaf-40a8-a347-011088009ea62026-08-11WarningsExact identifier
application number: M013
Fast Acting Pedia CraeACETAMINOPHENRandob Labs., Ltd.e069060f-fbb2-4c7a-b872-00b3ab86d01b2026-08-11WarningsExact identifier
application number: M013
ASPIRINASPIRINAmazon.com Services LLCc7cc0681-4c0b-4565-99df-d0168c8ba1ba2026-08-10WarningsExact identifier
application number: M013
GenCare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPioneer Life Sciences, LLCac8c4bdf-30c9-2b09-e053-2a95a90a9b672026-08-09WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN5bfd9841-c781-43be-b823-d334893ae6ed6
198440acetaminophen 500 MG Oral TabletSCD5bfd9841-c781-43be-b823-d334893ae6ed6
198440APAP 500 MG Oral TabletSY5bfd9841-c781-43be-b823-d334893ae6ed6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-507-62301420507621 BOTTLE in 1 CARTON (30142-507-62) > 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-08-182023-02-28NoNoCurrent
30142-507-78301420507781 BOTTLE in 1 CARTON (30142-507-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-08-180000-00-00NoNoCurrent
30142-507-83301420507831 BOTTLE in 1 CARTON (30142-507-83) / 225 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-08-210000-00-00NoNoCurrent