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 52 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equaline Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnited Natural Foods, Inc. dba UNFI739237a5-cc62-8ad6-e053-2991aa0a91f82024-12-17WarningsExact identifier
application number: M013
NOTTS - Muscle Aches and PainACETAMINOPHENVIVUNT PHARMA LLCe6741300-4573-2580-e053-2a95a90a599c2024-12-17WarningsExact identifier
application number: M013
Extra Strength Pain Reliever, Caseys 4goodACETAMINOPHEN 500MG, FILM-COATED CAPLETLil' Drug Store Products, Inc.e5fc5340-c224-e02b-e053-2a95a90a52972024-12-16WarningsExact identifier
application number: M013
Pain Reliever, Caseys 4goodACETAMINOPHEN 500 MG, TABLETLil' Drug Store Products, Inc.039d2cf1-57f6-4d9d-e063-6394a90a54922024-12-16WarningsExact identifier
application number: M013
Extra Strength Headache, Caseys 4goodACETAMINOPHEN, ASPIRIN, CAFFEINE TABLETLil' Drug Store Products, Inc.0425c6a8-a3ea-24ad-e063-6294a90ae15a2024-12-16WarningsExact identifier
application number: M013
Lil Drug Store Childrens Pain and FeverACETAMINOPHENLil' Drug Store Products, Inc.5fcd41ad-449f-4090-be19-eae4171de8912024-12-16WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGCVS Pharmacyb9e75551-1e50-9896-e053-2a95a90aafd42024-12-14WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGCVS Pharmacyb9e5df0e-06d3-6f72-e053-2995a90a2d072024-12-14WarningsExact identifier
application number: M013
Alka-Seltzer Heartburn and PainANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.2928e140-c868-5bf5-e063-6394a90ab0242024-12-13WarningsExact identifier
application number: M013
foster and thrive pain relieverACETAMINOPHENStrategic Sourcing Services LLCb8ee568c-80cf-4e35-865e-35516bdab0fd2024-12-13WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEStrive Pharmaceuticals Inc.c0de0bd2-4868-46dc-a20f-3ca02caaa26b2024-12-11WarningsExact identifier
application number: M013
Rite Aid Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATERite Aidb4797380-9cef-d640-e053-2a95a90a06652024-12-11WarningsExact identifier
application number: M013
Top Value Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICAROBONATETower Laboratories Ltd44babed8-cf38-1c12-e054-00144ff8d46c2024-12-11Warnings, Adverse reactionsExact identifier
application number: M013
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Companyb5e2300a-b77b-53cc-e053-2a95a90a7a6e2024-12-11WarningsExact identifier
application number: M013
EXTRA STRENGTH Headache Relief geltabsACETAMINOPHEN, ASPIRIN, CAFFEINEStrive Pharmaceuticals Inc.b432771a-4f7d-4d39-a038-d1561d8f67082024-12-11WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)223ffb2b-3ee5-4118-955b-bc4fa4e8a2e62024-12-10WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENUNFIe689c9e3-dd4d-c646-e053-2a95a90a4b6a2024-12-09WarningsExact identifier
application number: M013
DrKids Childrens Pain and FeverACETAMINOPHEN 80MG/PIECECalmCo LLCff4b0528-39a0-80d5-e053-6394a90a8a832024-12-07WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART972f09a7-2aa1-4b1b-a6dc-2c4578a078032024-12-05WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENDISCOUNT DRUG MARTe6feff0a-3347-194d-e053-2a95a90acd202024-12-05WarningsExact 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