FDA.reportPublic FDA data

Extra Strength Acetaminohpen

Product NDC
0904-5847
11-digit product format
009045847
Labeler code
0904
Product ID
0904-5847_528a4d65-08dc-4bec-8587-eb0c096dd8d1
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
LIQUID
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-07-02
Marketing end
2026-11-28
Substance
ACETAMINOPHEN
Active strength
500 mg/15mL
NDC exclude flag
No
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct0904-5847DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-58470904-5847-09DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…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
Extra Strength Acetaminohpen
Brand name suffix
Adult Rapid Burst Cherry

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/15mL

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
9e7543d9-6249-45b5-b67d-c1b439423b9cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-5847-09Extra Strength AcetaminohpenAdult Rapid Burst Cherry237 mL in 1 BOTTLE, PLASTICLIQUID2378

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5847-09ML - Milliliter0904-5847d546a8cf-60af-4317-a29c-f5c183aacdea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DEXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (ACETAMINOPHEN) LIQUID [MAJOR PHARMECEUTICALS]1
AcetaminophenACTIVE MOIETY362O9ITL9DEXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (ACETAMINOPHEN) LIQUID [MAJOR PHARMECEUTICALS]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPEXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (ACETAMINOPHEN) LIQUID [MAJOR PHARMECEUTICALS]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LEXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (ACETAMINOPHEN) LIQUID [MAJOR PHARMECEUTICALS]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAEXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (ACETAMINOPHEN) LIQUID [MAJOR PHARMECEUTICALS]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SEXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (ACETAMINOPHEN) LIQUID [MAJOR PHARMECEUTICALS]1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQEXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (ACETAMINOPHEN) LIQUID [MAJOR PHARMECEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (ACETAMINOPHEN) LIQUID [MAJOR PHARMECEUTICALS]1
SACCHARIN SODIUM ANHYDROUSINACTIVE INGREDIENTI4807BK602EXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (ACETAMINOPHEN) LIQUID [MAJOR PHARMECEUTICALS]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUEXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (ACETAMINOPHEN) LIQUID [MAJOR PHARMECEUTICALS]1
SORBITOLINACTIVE INGREDIENT506T60A25REXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (ACETAMINOPHEN) LIQUID [MAJOR PHARMECEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0REXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (ACETAMINOPHEN) LIQUID [MAJOR PHARMECEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5847EXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (ACETAMINOPHEN) LIQUID [MAJOR PHARMACEUTICALS]8Current NDC, Legacy NDC, 1 package rows20240829_9e7543d9-6249-45b5-b67d-c1b439423b9c.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 7 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFANTS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC112076c4-cac2-45ab-9c77-5573edae71802026-07-10WarningsExact identifier
application number: M013
AspirinASPIRINWal-Mart Stores Inc8ae16aa2-54bc-4c1a-aa36-93524199a67b2026-07-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWildman Business Group943c8f49-e65e-40bc-b364-3274df4d21a22026-07-09WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINFOODHOLD U.S.A., LLC9e09b4fb-e015-45ea-8b1c-27faf65572aa2026-07-09WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEWalgreen Companyf13fb7e9-50ea-4e2c-a442-38b1b5b315d72026-07-09WarningsExact identifier
application number: M013
Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60ACETAMINOPHEN 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETSHealth Pharma USA LLC34eb8a9b-d0ee-13e8-e063-6294a90a2fef2026-07-08WarningsExact identifier
application number: M013
Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mgACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MGHealth Pharma USA LLC3590d417-272b-ae4d-e063-6394a90a5dc62026-07-08WarningsExact identifier
application number: M013
GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHENACETAMINOPHENCabinet Health P.B.C.88884253-5a79-4ac1-b8ce-03966d8b509d2026-07-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHealth Pharma USA LLC671adabe-5f82-4599-a133-3f67ccb340792026-07-07WarningsExact identifier
application number: M013
Pain Reliever PlusACETAMINOPHEN, ASPIRIN, CAFFEINERugby Laboratoriesc3df1652-96a8-6043-e053-2995a90a2d262026-07-07WarningsExact identifier
application number: M013
Rapidol AspirinASPIRINPharmadel LLC00d9ab0d-ff25-784f-e063-6294a90a84972026-07-06WarningsExact identifier
application number: M013
AspirinASPIRINTrifecta Pharmaceuticals USA LLC227cefca-acc4-41d0-e063-6394a90a35b92026-07-06WarningsExact identifier
application number: M013
Extra Strength Pain AidACETAMINOPHEN, ASPIRIN, CAFFEINEHi-Tech Nutaceuticals, LLCa39e4b99-700d-0f5c-e053-2a95a90a6bd32026-07-06WarningsExact identifier
application number: M013
Nighttime Sleep AidACETAMINOPHEN, DIPHENHYDRAMINEHi-Tech Nutraceuticals, LLCa39e2bd6-3d0a-642b-e053-2995a90a42a02026-07-06WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa36be487-7a36-550f-e053-2a95a90a95c12026-07-06WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa39c524e-c131-d7fb-e053-2995a90a785b2026-07-06WarningsExact identifier
application number: M013
PAIN RELIEVERASPIRIN 81 MGHealth Pharma USA, LLCd60aed37-3a9e-46d1-e053-2995a90a1d1f2026-07-06WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDESelect Consumer Group55d0dceb-c9a9-778e-e063-6294a90a2ad72026-07-04WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINSelect Consumer Group3ca776c2-47ed-5107-e063-6394a90ac5df2026-07-03WarningsExact identifier
application number: M013
AspirinASPIRINRugby Laboratoriesf7ca9f4a-f8ef-46d2-9536-b69541e6653d2026-07-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307684acetaminophen 500 MG in 15 mL Oral SolutionPSN9e7543d9-6249-45b5-b67d-c1b439423b9c8
307684acetaminophen 33.3 MG/ML Oral SolutionSCD9e7543d9-6249-45b5-b67d-c1b439423b9c8
307684APAP 1000 MG per 30 ML Oral SolutionSY9e7543d9-6249-45b5-b67d-c1b439423b9c8
307684APAP 167 MG per 5 ML Oral SolutionSY9e7543d9-6249-45b5-b67d-c1b439423b9c8
307684APAP 33.3 MG/ML Oral SolutionSY9e7543d9-6249-45b5-b67d-c1b439423b9c8
307684APAP 500 MG per 15 ML Oral SolutionSY9e7543d9-6249-45b5-b67d-c1b439423b9c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5847-0900904584709237 mL in 1 BOTTLE, PLASTIC (0904-5847-09) 237 ml2009-07-022026-11-28NoNoCurrent