Cough and Cold HBP

Product NDC: 46122-705
11-digit product format: 461220705
Labeler code: 46122
Product ID: 46122-705_51e72030-1561-4329-8288-db3fcd4454d6
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amerisource Bergen
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-11-10
Substance: CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 4; 30 mg/1; mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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: Cough and Cold HBP
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORPHENIRAMINE MALEATE	4 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V1Q0O9OJ9Z	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1421985	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
0b58990f-2246-408e-9365-51f56bb6766c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46122-705-73	Cough and Cold HBP	8 in 1 BLISTER PACK	TABLET, FILM COATED	8		6
46122-705-73	Cough and Cold HBP	2 in 1 CARTON	TABLET, FILM COATED	2		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46122-705-73	EA - Each	46122-705	6b14acb6-b5a5-4cab-95c4-1696b0bc7aee	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46122-705	COUGH AND COLD HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [AMERISOURCE BERGEN]	5	Current NDC, Legacy NDC, 2 package rows	20250114_0b58990f-2246-408e-9365-51f56bb6766c.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 157 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	445e49a2-6ed0-434c-aaea-3ce14bc7df59	2024-08-12	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	d49b42ad-0ae0-48c9-adba-5fc2ced97764	2024-08-12	Warnings	Exact identifier application number: M012
RYMED	DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE	EDWARDS PHARMACEUTICALS, INC.	c1d6e914-74cc-4cdf-9587-7eaaa4a386e5	2024-08-12	Warnings	Exact identifier application number: M012
WesTussin DM NF	WESTUSSIN DM NF	Westminster Pharmaceuticals, LLC	4e0f9f97-a31c-41ac-9d6c-d81efd20fcef	2024-08-08	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	2f2a2864-af11-4240-bdad-a54aca58d01b	2024-08-07	Warnings	Exact identifier application number: M012
Cold plus Flu Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	0199aea2-a9c1-4c9d-8786-28b9dadc832e	2024-08-07	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	32d1ce6e-2617-4b50-a9e6-2e1941465dff	2024-08-07	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	07362db5-a372-4463-af8b-06e8783ca865	2024-08-07	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	1fb11d90-48bf-4baa-9b3a-5d64d81e3a06	2024-08-07	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	574774b2-9813-4799-9cd4-27e296dd8584	2024-08-07	Warnings	Exact identifier application number: M012
Cold Max Day and NIght	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	a92bcefb-ba29-4b3f-a60b-b4476ca8cf04	2024-08-07	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	778f1f5a-fd04-456f-90d0-998b93e774a5	2024-08-07	Warnings	Exact identifier application number: M012
Head Congestion plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	990f3232-bc75-45cf-8a50-cd7861d83f98	2024-08-07	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	0f5f25c6-7389-4285-b8d5-463cb7b6fcc4	2024-08-07	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	Care One (Retail Business Services, LLC.)	a9a5b39d-b4c8-414e-8fe7-4c0601f75197	2024-08-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	American Health Packaging	b94feeb6-f33f-410d-a9b0-776b1ccf34a9	2024-08-04	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	American Health Packaging	4cd8aee3-5522-434b-a1b1-9591bed3e9a6	2024-08-04	Warnings	Exact identifier application number: M012
Guaifenesin DM	GUAIFENESIN AND DEXTROMETHORPHAN	American Health Packaging	8632a655-7f5b-450f-95fa-62478a174e9c	2024-08-04	Warnings	Exact identifier application number: M012
Guaifenesin DM	GUAIFENESIN AND DEXTROMETHORPHAN	American Health Packaging	990906b3-c566-4f35-923c-060202ba48e0	2024-08-04	Warnings	Exact identifier application number: M012
Honey Lemon Flavor Cough Drops	HONEY LEMON FLAVOR MENTHOL	WHOLE FOODS MARKET, INC.	1eb7abdc-061f-0e18-e063-6294a90a3a65	2024-08-02	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1421985	chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Oral Tablet	PSN	0b58990f-2246-408e-9365-51f56bb6766c	6
1421985	chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Oral Tablet	SCD	0b58990f-2246-408e-9365-51f56bb6766c	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46122-705-73	46122070573	2 BLISTER PACK in 1 CARTON (46122-705-73) / 8 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2021-11-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Good Neighbor Pharmacy 44-689	Amerisource Bergen \| LNK International, Inc.	2026-01-20	HUMAN OTC DRUG LABEL	6