Childrens Acetaminophen

Product NDC
55319-288
11-digit product format
553190288
Labeler code
55319
Product ID
55319-288_95f74521-198c-4072-840a-fc1d58bed175
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-02-28
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55319-288DDiscontinued by firm2026-10-20
excluded packagepackage55319-28855319-288-04DDiscontinued 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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55319-288-04DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55319-288-04DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55319-288-04DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55319-288-04DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55319-288-04DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55319-288-04DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55319-288-04IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55319-288-04IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55319-288-04IInactivated by FDAbd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-288-042023-01-20C16284748780-1d6a99b39-b94c-a426-e053-dadaa90af4c2Drug Facts
55319-288-042022-01-28C16284748780-1d6a99b39-b94c-a426-e053-dadaa90af4c2Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]1
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]1
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55319-288-04553190288041 BOTTLE, PLASTIC in 1 BOX (55319-288-04) > 118 mL in 1 BOTTLE, PLASTIC2015-02-280000-00-00NoNoCurrent