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 53 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amazon Basics Honey Lemon Cough Drops 30ct	MENTHOL	Amazon	3e75838b-e1c9-2d42-e063-6294a90aab82	2026-02-01	Warnings	Exact identifier application number: M012
cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	HyVee Inc	5110526f-51fd-401e-ba52-520674d34f37	2026-02-01	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Amazon.com Service LLC	673996ab-6e57-4feb-8af3-d8b474741a8d	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strategic Sourcing Services, LLC	1d6c23d7-d1dc-4cba-8600-5762c18a0e27	2026-01-29	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Belmora LLC	3622e072-2784-c57e-e063-6394a90a8217	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M012
Night Time Cold and Flu ReadyInCase	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	P & L Development, LLC	e7dd763b-3005-4723-933b-171eb772afee	2026-01-29	Warnings	Exact identifier application number: M012
Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR	Softgel Healthcare Pvt Ltd	24bc9ae6-8e8f-c0a0-e063-6394a90a407f	2026-01-28	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	Softgel Healthcare Private Limited	229d1939-84a9-f18e-e063-6394a90aba30	2026-01-28	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	1fcbafaa-c871-db6d-e063-6394a90aab5e	2026-01-28	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	1f7a6375-ab66-9782-e063-6394a90a99f3	2026-01-28	Warnings	Exact identifier application number: M012
ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI	MEDWISE LIFESCIENCES INC.	4970b8bc-3c7b-4b8a-e063-6294a90a7f1b	2026-01-28	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR	Family Dollar (FAMILY WELLNESS)	fe3e74ba-31d9-4d50-ab61-ffb6aaa66085	2026-01-28	Warnings	Exact identifier application number: M012
Leader Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Cardinal Health 110, LLC. dba Leader	9b1a5dbe-39dd-4dbb-800c-0cef422ae7c5	2026-01-28	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	93d5b1db-e9ad-4a6a-b869-fd0d1a11df02	2026-01-27	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	53a3e6a7-d625-4393-95eb-bb6f86e86cc1	2026-01-27	Warnings	Exact identifier application number: M012
Dextromethorphan Hbr,Guaifenesin	DEXTROMETHORPHAN HBR,GUAIFENESIN	SOFTGEL HEALTHCARE PRIVATE LIMITED	2fbbfc7c-81a9-b647-e063-6394a90a55ac	2026-01-27	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	32074a31-326b-4aaf-e063-6394a90a0d40	2026-01-27	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	335b6ddd-fdc8-1120-e063-6394a90add41	2026-01-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	37e8ccd5-6be1-9aca-e063-6394a90a5263	2026-01-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	SOFTGEL HEALTHCARE PRIVATE LIMITED	2f7f078e-de04-9d53-e063-6394a90a409f	2026-01-27	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