FDA.reportPublic FDA data

pain and fever

Product NDC
0363-0161
Requested package NDC
0363-0161-10
11-digit product format
003630161
Labeler code
0363
Product ID
0363-0161_a8d51a9d-9f8e-4f8e-b110-95812944e759
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
2011-09-16
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 packagepackage0363-01610363-0161-10DDiscontinued by firm2026-10-15

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
0363-0161-10ML - Milliliter0363-016122c6668f-2cdc-4e3e-83bc-cbf90308ee9d12020-04-20
0363-0161-16ML - Milliliter0363-01615fc5d55e-7b38-4380-99a8-d5487f958c4f12020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]4
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]4
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]4
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]4
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]4
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]4
SORBITOLINACTIVE INGREDIENT506T60A25RPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]4
WATERINACTIVE INGREDIENT059QF0KO0RPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0161PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]9Legacy NDC20241106_f2e19aab-836d-404c-95bb-f659e40832cb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0161-10003630161101 BOTTLE in 1 CARTON (0363-0161-10) > 30 mL in 1 BOTTLE1 bottle2011-09-160000-00-00NoNoCurrent