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 2 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAX relief juniorACETAMINOPHENAkron Pharma Inc.0e43b885-3843-4f11-9a53-02a38c2283132026-08-31WarningsExact identifier
application number: M013
MAX relief juniorCHILDREN ACETAMINOPHENAkron Pharma Inc.d7874e4d-0b38-4bb1-9a62-aa4f66d9baf92026-08-31WarningsExact identifier
application number: M013
MAX relief junior GrapeCHILDREN ACETAMINOPHENAkron Pharma Inc.3c7a7f40-4963-4fd1-942e-93fa08a458302026-08-31WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5a615118-33c9-1520-e063-6394a90a21a62026-08-31WarningsExact identifier
application number: M013
acetaminophen extra strengthACETAMINOPHENSam's West Incdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d2026-08-28WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINHAWAII REPACK, INC.ac94cce3-9a39-41de-bb8b-10a5e5b8e83b2026-08-28WarningsExact identifier
application number: M013
AspirinASPIRINWinCo Foods, LLCa0a19cd1-eb8a-4773-be00-78de90d2a3c32026-08-28WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENFSA STORE INC.5502ef15-9f40-db56-e063-6394a90a2de42026-08-26WarningsExact identifier
application number: M013
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreens3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d2026-08-26WarningsExact identifier
application number: M013
HyVee Extra Strength Headache Relief CAPLETACETAMINOPHEN, ASPIRIN, CAFFEINEHyVee Inc495c75bf-c09a-accd-e063-6294a90a75ec2026-08-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
application number: M013
equate aspirinASPIRINWal-Mart Stores Incea3f8eed-7b70-4156-9586-125d27bf29a82026-08-19WarningsExact identifier
application number: M013
aspirin chewable, low doseASPIRINUnited Natural Foods, Inc. dba UNFI6a6ac7fe-91a4-4b55-979a-b53b51505d8b2026-08-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSam's West Inc1098d0e7-8202-4018-a2d2-b0c80ee58b562026-08-19WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINESafeway, Inc.5e77dca4-2ff8-4a8c-94bd-f224b680ca232026-08-19WarningsExact identifier
application number: M013
dg health pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLDolgencorp Inc4d1eddf0-eff7-4c47-b312-30dee08d9e5f2026-08-19WarningsExact 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