Childrens Cold and Cough Relief

Product NDC
55319-313
11-digit product format
553190313
Labeler code
55319
Product ID
55319-313_b9fef30b-c97f-4e1d-b345-f2fb38e76574
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-10-31
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
2020-12-31
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 productproduct55319-313DDiscontinued by firm2026-08-17
excluded packagepackage55319-31355319-313-04DDiscontinued by firm2026-08-17

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 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55319-313-04DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55319-313-04IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55319-313-04IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55319-313-04IInactivated by FDAbd6a592717d7…303034d00443…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-313-042023-01-20C16284748780-1d6a99b39-858d-a426-e053-dadaa90af4c2Drug Facts
55319-313-042022-01-28C16284748780-1d6a99b39-858d-a426-e053-dadaa90af4c2Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03CHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]1
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNCHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]1
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-313CHILDRENS COLD AND COUGH RELIEF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]6Legacy NDC20230122_ff712454-32df-4839-98d1-a6844a1bba96.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55319-313-04553190313041 BOTTLE, PLASTIC in 1 BOX (55319-313-04) > 118 mL in 1 BOTTLE, PLASTIC2015-10-310000-00-00NoNoCurrent