FDA.reportPublic FDA data

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Product NDC
0904-6536
Requested package NDC
0904-6536-20
11-digit product format
009046536
Labeler code
0904
Product ID
0904-6536_4dcf64c3-75c0-46b5-8579-dc9ae69429ac
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-10-31
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 packagepackage0904-65360904-6536-20DDiscontinued by firm2026-10-05

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
0904-6536-20ML - Milliliter0904-6536ab0d926a-cf83-4fcd-bdec-da5e1220f89012016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DMAPAP CHILDRENS (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DMAPAP CHILDRENS (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9MAPAP CHILDRENS (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMAPAP CHILDRENS (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8MAPAP CHILDRENS (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]1
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311MAPAP CHILDRENS (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMAPAP CHILDRENS (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMAPAP CHILDRENS (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMAPAP CHILDRENS (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SMAPAP CHILDRENS (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MAPAP CHILDRENS (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMAPAP CHILDRENS (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]1
SORBITOLINACTIVE INGREDIENT506T60A25RMAPAP CHILDRENS (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RMAPAP CHILDRENS (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMAPAP CHILDRENS (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-6536-20009046536201 BOTTLE, PLASTIC in 1 BOX (0904-6536-20) > 118 mL in 1 BOTTLE, PLASTIC2015-10-310000-00-00NoNoCurrent