FDA.reportPublic FDA data

Sunmark Infants Pain and Fever

Product NDC
49348-430
11-digit product format
493480430
Labeler code
49348
Product ID
49348-430_89bbd5b9-4e68-4f41-a7a4-2bf32e731d09
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
2011-09-26
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct49348-430DDiscontinued by firm2026-10-20
excluded packagepackage49348-43049348-430-30DDiscontinued 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 · 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 productproduct49348-430DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49348-43049348-430-30DDiscontinued 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
49348-430-30ML - Milliliter49348-43036537126-41b6-4555-806e-510626b59b3712014-04-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-430SUNMARK INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [STRATEGIC SOURCING SERVICES LLC]7Legacy NDC20241122_83acab73-3efb-4ea6-ad03-31b82dd017b9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-430-30493480430301 BOTTLE in 1 CARTON (49348-430-30) > 59 mL in 1 BOTTLE1 bottle2011-09-260000-00-00NoNoCurrent