FDA.reportPublic FDA data

Dibromm Cold and Allergy

Product NDC
63868-241
11-digit product format
638680241
Labeler code
63868
Product ID
63868-241_6f5a82da-9dbb-4767-b988-6ed771eb3b57
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine maleate, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-07-31
Substance
BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2; 5 mg/10mL; mg/10mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dibromm Cold and Allergy
Brand name suffix
Childrens
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMPHENIRAMINE MALEATE2 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIXA7C9ZN03, 04JA59TNSJ
Rxcui1053258

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-241-04Dibromm Cold and AllergyChildrens118 mL in 1 BOTTLE, PLASTICLIQUID1186
63868-241-04Dibromm Cold and AllergyChildrens1 in 1 BOXLIQUID16
63868-241-08Dibromm Cold and AllergyChildrens1 in 1 BOXLIQUID16
63868-241-08Dibromm Cold and AllergyChildrens237 mL in 1 BOTTLE, PLASTICLIQUID2376

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-241-04ML - Milliliter63868-241fc8bbbfe-d36c-4038-963c-bce9caf0414712022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNDIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SORBITOLINACTIVE INGREDIENT506T60A25RDIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KDIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
WATERINACTIVE INGREDIENT059QF0KO0RDIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-241DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]6Current NDC, Legacy NDC, 4 package rows20240423_ea285d5a-9eb4-4f71-bb1b-4e24a8972819.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNea285d5a-9eb4-4f71-bb1b-4e24a89728196
1053258brompheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDea285d5a-9eb4-4f71-bb1b-4e24a89728196
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral ElixirSYea285d5a-9eb4-4f71-bb1b-4e24a89728196
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSYea285d5a-9eb4-4f71-bb1b-4e24a89728196
1053258brompheniramine maleate 2 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSYea285d5a-9eb4-4f71-bb1b-4e24a89728196

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-241-04638680241041 BOTTLE, PLASTIC in 1 BOX (63868-241-04) / 118 mL in 1 BOTTLE, PLASTIC2015-07-310000-00-00NoNoCurrent
63868-241-08638680241081 BOTTLE, PLASTIC in 1 BOX (63868-241-08) / 237 mL in 1 BOTTLE, PLASTIC2015-07-310000-00-00NoNoCurrent