FDA.reportPublic FDA data

childrens pain and fever

Product NDC
0363-0800
Requested package NDC
0363-0800-26
11-digit product format
003630800
Labeler code
0363
Product ID
0363-0800_bc04545e-9de1-4aa9-8a88-9c739f359d62
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Walgreen Company
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1993-10-08
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage0363-08000363-0800-26DDiscontinued 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 · 1 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 packagepackage0363-08000363-0800-26DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0800-26ML - Milliliter0363-08005adf48a5-2e5c-4490-91c1-e4fa741cb12e12014-08-01
0363-0800-34ML - Milliliter0363-0800b2fa95a9-ba38-4a4e-ad98-d236baf3698112022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]3
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]3
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]3
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0800CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]8Legacy NDC20240509_bdc5dc8f-8f80-4d7a-9f79-54f6a2030011.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0800-26003630800261 BOTTLE in 1 CARTON (0363-0800-26) > 118 mL in 1 BOTTLE1 bottle1993-10-080000-00-00NoNoCurrent