pain and fever

Product NDC
37808-946
Requested package NDC
37808-946-16
11-digit product format
378080946
Labeler code
37808
Product ID
37808-946_e3f9257a-b5a8-41c7-873a-95a6504f2ae6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
H E B
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-12-01
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 packagepackage37808-94637808-946-16DDiscontinued 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 · 2 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 packagepackage37808-94637808-946-16DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37808-94637808-946-16DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
SORBITOLINACTIVE INGREDIENT506T60A25RPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
WATERINACTIVE INGREDIENT059QF0KO0RPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-946-16378080946161 BOTTLE, DROPPER in 1 CARTON (37808-946-16) > 59 mL in 1 BOTTLE, DROPPER2011-12-010000-00-00NoNoCurrent