FDA.reportPublic FDA data

Acetaminophen

Product NDC
0904-7481
11-digit product format
009047481
Labeler code
0904
Product ID
0904-7481_072e6688-f9f2-409b-8b89-c558e785ba16
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-15
Substance
ACETAMINOPHEN
Active strength
1000 mg/30mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
ACETAMINOPHEN1000 mg/30mL

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
307684Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e1a55e0d-bb86-4515-8436-51a74b403685Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7481-59Acetaminophen237 mL in 1 BOTTLE, PLASTICSOLUTION2373

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7481-59ML - Milliliter0904-7481c028a2ba-5360-4cf3-a565-3fe24c61bfe812025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7481ACETAMINOPHEN SOLUTION [MAJOR PHARMACEUTICALS]1Current NDC, 1 package rows20241009_e1a55e0d-bb86-4515-8436-51a74b403685.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
307684acetaminophen 500 MG in 15 mL Oral SolutionPSNe1a55e0d-bb86-4515-8436-51a74b4036853
307684acetaminophen 33.3 MG/ML Oral SolutionSCDe1a55e0d-bb86-4515-8436-51a74b4036853
307684APAP 1000 MG per 30 ML Oral SolutionSYe1a55e0d-bb86-4515-8436-51a74b4036853
307684APAP 167 MG per 5 ML Oral SolutionSYe1a55e0d-bb86-4515-8436-51a74b4036853
307684APAP 33.3 MG/ML Oral SolutionSYe1a55e0d-bb86-4515-8436-51a74b4036853
307684APAP 500 MG per 15 ML Oral SolutionSYe1a55e0d-bb86-4515-8436-51a74b4036853

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7481-5900904748159237 mL in 1 BOTTLE, PLASTIC (0904-7481-59) 237 ml2021-07-15NoNoCurrent