FDA.reportPublic FDA data

Day Time

Product NDC
30142-656
Requested package NDC
30142-656-40
11-digit product format
301420656
Labeler code
30142
Product ID
30142-656_5deba051-8078-464f-94f7-b3b85dfbf4a5
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan HBr, Phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Kroger Company
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2006-06-11
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/15mL; mg/15mL; mg/15mL
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 packagepackage30142-65630142-656-40DDiscontinued by firm2026-10-05

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 packagepackage30142-65630142-656-40DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage30142-65630142-656-40DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
30142-656-30ML - Milliliter30142-656eb47faf9-374a-437b-9762-cdaaa96b3e9c12012-07-24
30142-656-38ML - Milliliter30142-65641a82839-8843-490a-a086-0394da08c1a212012-07-24
30142-656-40ML - Milliliter30142-65624f70cb7-1349-49d1-8fed-aed14555ef8212013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
MENTHOLINACTIVE INGREDIENTL7T10EIP3ADAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
SUCROSEINACTIVE INGREDIENTC151H8M554DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
WATERINACTIVE INGREDIENT059QF0KO0RDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]5
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
DOXYLAMINEACTIVE MOIETY95QB77JKPLNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
MENTHOLINACTIVE INGREDIENTL7T10EIP3ANITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
SUCROSEINACTIVE INGREDIENTC151H8M554NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RNITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-656DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [KROGER COMPANY]9Legacy NDC20241025_88dd9585-d18c-4f09-bc1f-07ef1e631390.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-656-4030142065640354 mL in 1 BOTTLE (30142-656-40) 354 ml2007-10-280000-00-00NoNoCurrent