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: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Dibromm Cold and Allergy
Brand name suffix: Childrens
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BROMPHENIRAMINE MALEATE	2 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE	5 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
IXA7C9ZN03	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1053258	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ea285d5a-9eb4-4f71-bb1b-4e24a8972819	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63868-241-04	Dibromm Cold and AllergyChildrens	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118	6
63868-241-04	Dibromm Cold and AllergyChildrens	1 in 1 BOX	LIQUID	1	6
63868-241-08	Dibromm Cold and AllergyChildrens	1 in 1 BOX	LIQUID	1	6
63868-241-08	Dibromm Cold and AllergyChildrens	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-241-04	ML - Milliliter	63868-241	fc8bbbfe-d36c-4038-963c-bce9caf04147	1	2022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	IXA7C9ZN03	DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
BROMPHENIRAMINE	ACTIVE MOIETY	H57G17P2FN	DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DIBROMM 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
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-241	DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	6	Current NDC, Legacy NDC, 4 package rows	20240423_ea285d5a-9eb4-4f71-bb1b-4e24a8972819.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 74 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SF Honey Lemon Cough Drops	MENTHOL	The Kroger Co.	43281bd1-f8a7-02a4-e054-00144ff8d46c	2025-12-17	Warnings	Exact identifier application number: M012
Kroger Cherry Cough Drops	MENTHOL	Kroger	a2e1d1f5-9b19-1704-e053-2a95a90abb51	2025-12-17	Warnings	Exact identifier application number: M012
Tussin Multi Symptom Cold CF Adult	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE	Major Pharmaceuticals	a9958b7d-7060-422b-a098-c1925c246081	2025-12-17	Warnings	Exact identifier application number: M012
Childrens Mucus Relief Cough Cherry Liquid	DEXTROMETHORPHAN HBR, GUAIFENSIN	Topco Associates	3170748e-b09f-4c07-9927-df43771166c5	2025-12-16	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	ca6d43cf-0d1f-4d3c-be7e-e3ac6a24f4fe	2025-12-16	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	e70d0784-53bc-4910-aade-3c9ad6e36441	2025-12-16	Warnings	Exact identifier application number: M012
Pain and Sinus	ACETAMINOPHEN AND PHENYLEPHRINE	JHK Inc dba American Safety & First Aid	88f86f5a-cc2b-4c75-b7a4-f2021922280b	2025-12-16	Warnings	Exact identifier application number: M012
Severe Congestion and Cough, Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	Walgreen Company	b75af815-9bd4-4a7a-bc68-f42f4af50699	2025-12-16	Warnings	Exact identifier application number: M012
Cough Relief Nighttime	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	fe5fd29e-7f81-4633-8c3b-010d68abe701	2025-12-16	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	e0a62fa1-9f8a-4770-b28b-1f4f02a762e0	2025-12-16	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	8c4b59b8-dfab-4f4a-9966-f07b026a758a	2025-12-16	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	QUALITY CHOICE (Chain Drug Marketing Association)	df866cf6-0526-4e61-ac9b-245b57dd5df6	2025-12-16	Warnings	Exact identifier application number: M012
Severe Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	c89200b6-4adb-452e-b931-07f631dad641	2025-12-16	Warnings	Exact identifier application number: M012
ONESSIP ADULT DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	MEDWISE LIFESCIENCES INC.	45fa9159-d74c-063a-e063-6294a90a3ed0	2025-12-15	Warnings	Exact identifier application number: M012
SudoGest Nasal Decongestant	PSEUDOEPHEDRINE HCL	Major Pharmaceuticals	5229f4b2-a194-46f8-a0bc-4510fbe52075	2025-12-15	Warnings	Exact identifier application number: M012
Topcare Nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	f2b2467f-2d9b-4742-b90a-95975c3b694f	2025-12-13	Warnings	Exact identifier application number: M012
Menthol Cough Drop	MENTHOL	HEB	39178eb7-ada9-30bf-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
SF Menthol Cough Drop	MENTHOL	HEB	3a443179-b7a6-3242-e054-00144ff8d46c	2025-12-13	Warnings	Exact identifier application number: M012
Cherry cough drop	MENTHOL	HEB	39bd0ca1-348f-0ce1-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
Strawberry Cough Drops	MENTHOL	HEB	766236e2-3302-2232-e053-2991aa0af503	2025-12-13	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IXA7C9ZN03	BROMPHENIRAMINE MALEATE	980-71-2	BROMPHENIRAMINE MALEATE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1053258	brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	ea285d5a-9eb4-4f71-bb1b-4e24a8972819	6
1053258	brompheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	ea285d5a-9eb4-4f71-bb1b-4e24a8972819	6
1053258	brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Elixir	SY	ea285d5a-9eb4-4f71-bb1b-4e24a8972819	6
1053258	brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution	SY	ea285d5a-9eb4-4f71-bb1b-4e24a8972819	6
1053258	brompheniramine maleate 2 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	ea285d5a-9eb4-4f71-bb1b-4e24a8972819	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-241-04	63868024104	1 BOTTLE, PLASTIC in 1 BOX (63868-241-04) / 118 mL in 1 BOTTLE, PLASTIC	2015-07-31	0000-00-00	No	No	Current
63868-241-08	63868024108	1 BOTTLE, PLASTIC in 1 BOX (63868-241-08) / 237 mL in 1 BOTTLE, PLASTIC	2015-07-31	0000-00-00	No	No	Current