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 56 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Publix Fast Relief EffervescentASPIRIN, CITRIC ACID, SODIUM BICARBONATEPublix Super Markets Inc.73051f16-2569-7394-e053-2991aa0a53592024-11-13WarningsExact identifier
application number: M013
Quality Choice Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association70d265de-ff94-e0e4-e053-2a91aa0a962a2024-11-13WarningsExact identifier
application number: M013
Quality Choice Extra Strength Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association9f7d0c96-a561-a8a0-e053-2995a90a250b2024-11-13WarningsExact identifier
application number: M013
WinCo Foods Effervescent Antacid and Pain ReliefASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLETWinCo Foods, LLC0c8a755a-089f-477f-97e9-0dd6fdfbe99d2024-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENKroger Company8fb19444-f0e0-4d26-81e8-6a4b835056d82024-11-12WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWALMART INC.59d01f72-4575-48e2-b914-b6a6456ca7d22024-11-11WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENKroger Companyd181560c-1c39-4f2e-8a17-996224ca040f2024-11-09WarningsExact identifier
application number: M013
Childrens TylenolACETAMINOPHENKenvue Brands LLCbabcb210-6a47-46ef-b4ea-bdde80411cd32024-11-08WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINAcme United Corporationf7f9dc46-a945-7ae3-e053-6394a90a11922024-11-08WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCdd87e342-b0cb-4111-9f15-415dbcda4b772024-11-07WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC0c5fdda8-5049-46de-e063-6294a90a592b2024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC46ddbfde-54ab-4373-b832-b9c0620b1e9d2024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC333f6231-3778-4c1f-9558-2afddca22c862024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC34247a3b-0846-4086-becd-76e630b3b7212024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCa51c2deb-c703-4dc8-9255-8ac9fe6351702024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCce0a1fbc-7345-462b-b0da-c7149bdc288c2024-11-07WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC015a6179-bacb-452d-b594-4de628ddc11d2024-11-07WarningsExact identifier
application number: M013
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLCde5c6654-56c5-40d3-a286-f04ed47ac7c82024-11-07WarningsExact identifier
application number: M013
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATEAcme United Corporationf7bf126d-a6f1-231a-e053-6294a90a04e12024-11-07WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company49021ae8-9655-4885-9f74-52df4cdcb26f2024-11-07WarningsExact 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