FDA.reportPublic FDA data

Health Mart Cold and Cough

Product NDC
62011-0063
Requested package NDC
62011-0063-1
11-digit product format
620110063
Labeler code
62011
Product ID
62011-0063_1d1a0673-4bd4-4b13-916b-c5948c3bb2f1
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-01-12
Marketing end
0000-00-00
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2 mg/10mL; mg/10mL; mg/10mL
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 packagepackage62011-006362011-0063-1DDiscontinued by firm2026-10-16

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 packagepackage62011-006362011-0063-1DDiscontinued 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
62011-0063-1ML - Milliliter62011-0063cab9d937-c031-49a3-aa7c-63598fd777d812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03HEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MCKESSON]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHHEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MCKESSON]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MCKESSON]1
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNHEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MCKESSON]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSHEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MCKESSON]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MCKESSON]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MCKESSON]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MCKESSON]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MCKESSON]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MCKESSON]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MCKESSON]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MCKESSON]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYHEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MCKESSON]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUHEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MCKESSON]1
SORBITOLINACTIVE INGREDIENT506T60A25RHEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MCKESSON]1
WATERINACTIVE INGREDIENT059QF0KO0RHEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0063HEALTH MART COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [STRATEGIC SOURCING SERVICES LLC]6Legacy NDC20241120_6f587e40-23b3-4419-b49c-7002fd938e5d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0063-1620110063011 BOTTLE in 1 CARTON (62011-0063-1) > 118 mL in 1 BOTTLE1 bottle2012-01-120000-00-00NoNoCurrent