Childrens Cold and Allergy Relief

Product NDC: 70677-0101
11-digit product format: 706770101
Labeler code: 70677
Product ID: 70677-0101_73e310bf-4f17-40a6-8d62-d71066b853b2
Type: HUMAN OTC DRUG
Nonproprietary name: Brompheniramine maleate, Phenylephrine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-01-31
Marketing end: 2026-12-28
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
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: Childrens Cold and Allergy Relief

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
d64fe757-9948-4727-b5dd-1f8e4e4763e2	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	Strength	SPL version
70677-0101-1	Childrens Cold and Allergy Relief	1 in 1 BOX	LIQUID	1		3
70677-0101-1	Childrens Cold and Allergy Relief	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70677-0101-1	ML - Milliliter	70677-0101	3a05e8df-80ac-4a00-88e0-7d947dc6d62b	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70677-0101	CHILDRENS COLD AND ALLERGY RELIEF (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [STRATEGIC SOURCING SERVICES LLC]	3	Current NDC, Legacy NDC, 2 package rows	20240601_d64fe757-9948-4727-b5dd-1f8e4e4763e2.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 82 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	a6a2dd4a-a3c8-2dfa-e053-2995a90ada86	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	bd49121c-7cba-c51f-e053-2995a90a921e	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare, LLC.	a6b8dc25-0fb9-1823-e053-2a95a90adf93	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	c2232241-6e57-1427-e053-2995a90a488a	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels	ACETAMINOPHEN, CHLORPHENIRAMINE MALAEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51dec468-fbb2-3489-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	d7711cd6-5058-548d-e053-2a95a90ac54d	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	a2f0285b-8550-fd26-e053-2995a90ab615	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	f6c73f61-f4fc-377f-e053-6294a90a3797	2025-12-04	Warnings	Exact identifier application number: M012
Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Bayer Healthcare LLC.	a32e2a5e-9aa0-4e7c-e053-2995a90a3190	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	e2877488-3539-cba2-e053-2995a90a6005	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cough and Sore Throat FizzyChews	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	14951faa-9476-6f29-e063-6394a90a14c7	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gels	ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION	Bayer HealthCare LLC.	0c120569-622d-3a23-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold and Flu FizzyChews	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	149330be-24bd-b4a4-e063-6394a90a9007	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN	Bayer HealthCare LLC.	5278a128-41ec-4494-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Orange Zest	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	53188c41-3f13-311b-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Day and Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	75894849-a0ba-57be-e053-2a91aa0a049a	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Sparkling Original	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	531ab703-179a-70ad-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	7588ea67-68a9-4dc0-e053-2991aa0aa471	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold and Cough	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	75862805-2cfe-fb45-e053-2991aa0a1403	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5172dc01-4e7f-3307-e054-00144ff8d46c	2025-12-04	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	d64fe757-9948-4727-b5dd-1f8e4e4763e2	3
1053258	brompheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	d64fe757-9948-4727-b5dd-1f8e4e4763e2	3
1053258	brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Elixir	SY	d64fe757-9948-4727-b5dd-1f8e4e4763e2	3
1053258	brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution	SY	d64fe757-9948-4727-b5dd-1f8e4e4763e2	3
1053258	brompheniramine maleate 2 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	d64fe757-9948-4727-b5dd-1f8e4e4763e2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70677-0101-1	70677010101	1 BOTTLE, PLASTIC in 1 BOX (70677-0101-1) / 118 mL in 1 BOTTLE, PLASTIC	2020-01-31	2026-12-28	No	No	Current