FDA.reportPublic FDA data

sunmark nite time

Product NDC
49348-061
Requested package NDC
49348-061-39
11-digit product format
493480061
Labeler code
49348
Product ID
49348-061_760b7263-e151-4c9c-b809-7d6be652150a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-11-21
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
650 mg/30mL; mg/30mL; mg/30mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49348-06149348-061-39DDiscontinued by firm2026-09-14

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 · 1 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 packagepackage49348-06149348-061-39DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-061-37ML - Milliliter49348-061142f29d6-6f45-4a9a-a079-29c1f68f96db12013-06-04
49348-061-39ML - Milliliter49348-061d5288aec-decd-4c76-b2d7-4a9ab30f7efc12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHSUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2SUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSSUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4
DOXYLAMINEACTIVE MOIETY95QB77JKPLSUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MSUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SSUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SSUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4
WATERINACTIVE INGREDIENT059QF0KO0RSUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MCKESSON]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-061SUNMARK NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [STRATEGIC SOURCING SERVICES LLC]10Legacy NDC20241109_ab13a5e8-0182-49e9-825b-7a558ce11055.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-061-3949348006139355 mL in 1 BOTTLE (49348-061-39) 355 ml2011-11-210000-00-00NoNoCurrent