Childrens Pain and Fever Acetaminophen

Product NDC
0536-3606
11-digit product format
005363606
Labeler code
0536
Product ID
0536-3606_94679ccd-44e7-4903-841d-fdc9e998fa26
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Rugby
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-03-16
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct0536-3606DDiscontinued by firm2026-10-15
excluded packagepackage0536-36060536-3606-96DDiscontinued 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 · 26 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 packagepackage0536-3606-96DDiscontinued 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 packagepackage0536-3606-96DDiscontinued 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 packagepackage0536-3606-96DDiscontinued 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 packagepackage0536-3606-96DDiscontinued 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 packagepackage0536-3606-96DDiscontinued 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 packagepackage0536-3606-96DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-3606-96DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-3606-96DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-3606-96DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-3606-96DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-3606-96DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-3606-96DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0536-3606-96EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
0536-3606-96ML - Milliliter0536-3606cd713eae-b737-4dbf-aaa0-df9a9383d14312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DCHILDRENS PAIN AND FEVER ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY]1
AcetaminophenACTIVE MOIETY362O9ITL9DCHILDRENS PAIN AND FEVER ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CHILDRENS PAIN AND FEVER ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS PAIN AND FEVER ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY]1
CherryINACTIVE INGREDIENTBUC5I9595WCHILDRENS PAIN AND FEVER ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPCHILDRENS PAIN AND FEVER ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY]1
Corn SyrupINACTIVE INGREDIENT9G5L16BK6NCHILDRENS PAIN AND FEVER ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY]1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS PAIN AND FEVER ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS PAIN AND FEVER ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS PAIN AND FEVER ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY]1
Sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS PAIN AND FEVER ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY]1
SorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS PAIN AND FEVER ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY]1
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS PAIN AND FEVER ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY]1
WaterINACTIVE INGREDIENT059QF0KO0RCHILDRENS PAIN AND FEVER ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEECHILDRENS PAIN AND FEVER ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [RUGBY]1