FDA.reportPublic FDA data

sunmark childrens pain and fever

Product NDC
49348-119
11-digit product format
493480119
Labeler code
49348
Product ID
49348-119_b0994c40-4f38-436f-8ef8-23799e9d9ce5
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-04-28
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct49348-119DDiscontinued by firm2026-10-15
excluded packagepackage49348-11949348-119-34DDiscontinued 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 productproduct49348-119DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49348-11949348-119-34DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
49348-119-34ML - Milliliter49348-119b7649938-e0c3-4bd9-9c60-b989cba85e7112014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8SUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJSUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LSUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SSUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XSUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2
SORBITOLINACTIVE INGREDIENT506T60A25RSUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2
WATERINACTIVE INGREDIENT059QF0KO0RSUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MCKESSON]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-119SUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [STRATEGIC SOURCING SERVICES LLC]9Legacy NDC20241027_1dd2a128-3da4-4b5e-b467-5317f72324eb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-119-34493480119341 BOTTLE in 1 CARTON (49348-119-34) > 118 mL in 1 BOTTLE1 bottle2014-04-280000-00-00NoNoCurrent