FDA.reportPublic FDA data

Childrens Pain and Fever

Product NDC
41250-631
11-digit product format
412500631
Labeler code
41250
Product ID
41250-631_080bb111-e7dc-4d03-9294-029879f92835
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Meijer Distribution Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-05-05
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41250-63141250-631-34DDiscontinued by firm2026-10-20

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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41250-63141250-631-34DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41250-63141250-631-34DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
Childrens Pain and Fever
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

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
307668Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
be841460-98b4-4448-a494-09ff161fd131Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-631-00Childrens Pain and Fever236 mL in 1 BOTTLESUSPENSION2368
41250-631-00Childrens Pain and Fever1 in 1 CARTONSUSPENSION18
41250-631-26Childrens Pain and Fever1 in 1 CARTONSUSPENSION18
41250-631-26Childrens Pain and Fever118 mL in 1 BOTTLESUSPENSION1188
41250-631-34Childrens Pain and Fever2 in 1 CARTONSUSPENSION28
41250-631-34Childrens Pain and Fever118 mL in 1 BOTTLESUSPENSION1188

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-631CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MEIJER DISTRIBUTION INC]7Current NDC, Legacy NDC, 6 package rows20241019_be841460-98b4-4448-a494-09ff161fd131.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 47 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOOD REMEDIES Extra Strength Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d642d8e-c154-a970-e063-6294a90a03bf2025-03-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac42025-03-07WarningsExact identifier
application number: M013
Redicare Non-Aspirin 500mgREDICARE NON-ASPIRIN, ACETAMINOPHEN 500MGRedicare LLC2f229898-1777-732c-e063-6394a90a76bc2025-03-04Warnings, Adverse reactionsExact identifier
application number: M013
Major Extra Strength Acetaminophen LiquidACETAMINOPHENMajor Pharmaceuticals2f3af4dd-45d5-87b4-e063-6294a90ab3cc2025-02-28WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINNCS HealthCare of KY, LLC dba Vangard Labsed9a71d6-a56e-416a-bb89-6d41307efc5a2025-02-27WarningsExact identifier
application number: M013
AspirinASPIRINPD-Rx Pharmaceuticals, Inc.77429b7f-78e4-42c0-8679-ae8da17488482025-02-26WarningsExact identifier
application number: M013
AeroTab Non-AspirinACETAMINOPHEN 500MG ESAero Healthcarefaa3a4ef-3c70-06ca-e053-6394a90a512d2025-02-26WarningsExact identifier
application number: M013
Bufferin Regular Strength Pain ReliefASPIRINGenomma Lab USA3543b2bf-1062-468a-a5dc-eabb2408af8c2025-02-25WarningsExact identifier
application number: M013
Calmour Childrens Acetaminophen Strips ChewableACETAMINOPHEN ORAL CHEWABLE 80 MGCalmourae47b027-4f29-45bb-a8bd-8129789328352025-02-22WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLCf9de7c2f-016b-4f40-8b5e-141ad194be972025-02-20WarningsExact identifier
application number: M013
Genexa Acetaminophen PM Extra StrengthACETAMINOPHENGenexa Inc.d82cf6f3-a291-ca2b-e053-2a95a90a6de12025-02-20WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENAdvagen Pharma Limited8b9456c9-a56b-4748-adb8-c66d6bf072e82025-02-19WarningsExact identifier
application number: M013
Genexa Childrens AcetaminophenACETAMINOPHENGenexa Inc.d89fd9d8-d88e-3968-e053-2a95a90afc5f2025-02-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.debfa787-7a48-48b5-94b0-6128205240322025-02-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.b16e5dcf-b290-4ff2-a150-4b875647ec9a2025-02-19WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCbb6533e5-e6a9-488c-b8ab-a6a06e87ede92025-02-18WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCc830320e-72ba-48ff-a4cd-250ac5650bf02025-02-18WarningsExact identifier
application number: M013
Aspirina CapletsASPIRINBayer HealthCare LLC.2e6f5ba8-8e8b-6059-e063-6394a90adcd52025-02-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.da7d95af-6583-429d-8d04-e0424f32e9ad2025-02-17WarningsExact identifier
application number: M013
GOODYS Mental AlertASPIRIN AND CAFFEINEMedtech Products Inc.31ef6d07-d314-4d09-abcd-389ba66cbcc52025-02-17WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNbe841460-98b4-4448-a494-09ff161fd1318
307668acetaminophen 32 MG/ML Oral SuspensionSCDbe841460-98b4-4448-a494-09ff161fd1318
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYbe841460-98b4-4448-a494-09ff161fd1318
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYbe841460-98b4-4448-a494-09ff161fd1318
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYbe841460-98b4-4448-a494-09ff161fd1318
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYbe841460-98b4-4448-a494-09ff161fd1318
307668APAP 32 MG/ML Oral SuspensionSYbe841460-98b4-4448-a494-09ff161fd1318

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-631-00412500631001 BOTTLE in 1 CARTON (41250-631-00) / 236 mL in 1 BOTTLE1 bottle2025-06-30NoNoCurrent
41250-631-26412500631261 BOTTLE in 1 CARTON (41250-631-26) / 118 mL in 1 BOTTLE1 bottle1998-05-050000-00-00NoNoCurrent
41250-631-34412500631342 BOTTLE in 1 CARTON (41250-631-34) > 118 mL in 1 BOTTLE2 bottle1998-05-050000-00-00NoNoCurrent