ED A-HIST DM

Product NDC: 0485-0171
11-digit product format: 004850171
Labeler code: 0485
Product ID: 0485-0171_4742a150-3418-b7c6-e063-6294a90adcda
Type: HUMAN OTC DRUG
Nonproprietary name: DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form: LIQUID
Route: ORAL
Labeler: EDWARDS PHARMACEUTICALS, INC.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-09-11
Substance: DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 15; 4; 10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: ED A-HIST DM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/5mL
CHLORPHENIRAMINE MALEATE	4 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE	10 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
V1Q0O9OJ9Z	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
1086443	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
e0e2b117-62bc-4132-9f7c-fe2a912052b1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-01-31	ED-EDA-HISTDM 0171
2024-01-30	ED-EDA-HISTDM 0171
2020-04-08	ED-EDA-HISTDM 0171
2020-01-31	ED-EDA-HISTDM 0171

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0485-0171-16	ED A-HIST DM	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0485-0171-16	ML - Milliliter	0485-0171	ace451c0-1253-46ba-ab7a-e92a18c08ad7	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
POTASSIUM CITRATE	INACTIVE INGREDIENT	EE90ONI6FF	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0485-0171	ED A-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 1 package rows	20241228_e0e2b117-62bc-4132-9f7c-fe2a912052b1.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 84 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Afrin Original Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	0f5ec576-f788-40aa-9088-0dd672e3cc7c	2025-12-04	Warnings	Exact identifier application number: M012
Adult Long Lasting Cough Relief	DEXTROMETHORPHAN HBR	Shield Pharmaceuticals Corp	432a79a9-c69d-4514-894a-7832e1b745ef	2025-12-04	Warnings	Exact identifier application number: M012
GENCONTUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	69d16d25-b09b-430e-8e01-0962d840dc21	2025-12-04	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL	H E B	7c04ab14-af28-4598-90ef-56ac11902c7d	2025-12-04	Warnings	Exact identifier application number: M012
Desgen Pediatric	DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL	Kramer Novis	12425c1b-8bdc-446b-83dd-95e05a4d9b8c	2025-12-04	Warnings	Exact identifier application number: M012
Presgen B	DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	5befa829-32bd-4978-8a0e-1d6513ff37a4	2025-12-03	Warnings	Exact identifier application number: M012
TUSSLIN	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kramer Novis	987e19a5-032f-44e9-b4c7-8a764d502695	2025-12-03	Warnings	Exact identifier application number: M012
DayTime Relief, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTION	Lil' Drug Store Products, Inc.	450e8974-8ff8-4b82-e063-6394a90a9366	2025-12-03	Warnings	Exact identifier application number: M012
Nighttime Relief, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTION	Lil' Drug Store Products, Inc.	4510223f-1c88-2796-e063-6394a90a18ac	2025-12-03	Warnings	Exact identifier application number: M012
Carolina Crud Crusher	DEXTROMETHORPHAN HBR, GUAIFENESIN	Weeks & Leo Co., Inc.	0b606683-7d68-cca5-e063-6394a90a6f58	2025-12-03	Warnings	Exact identifier application number: M012
Capmist DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Capital Pharmaceutical, LLC	63733ac3-859e-4a8e-8717-d852bd303408	2025-12-03	Warnings	Exact identifier application number: M012
ALA-HIST IR	DEXBROMPHENIRAMINE MALEATE	Poly Pharmaceuticals, Inc.	0d203b5c-8b10-428b-8703-17be6b4ce6eb	2025-12-03	Warnings	Exact identifier application number: M012
ALAHIST DM	DEXTROMETHORPHAN HBR, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Poly Pharmaceuticals, Inc.	fdaa062d-110e-798d-e053-6394a90a755c	2025-12-03	Warnings	Exact identifier application number: M012
Alahist D	PHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Poly Pharmaceuticals, Inc.	a1b8533a-ef8b-57cc-e053-2995a90a5d9e	2025-12-03	Warnings	Exact identifier application number: M012
Alahist PE	DEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	ada2d582-5813-2029-e053-2a95a90ae567	2025-12-03	Warnings	Exact identifier application number: M012
Benadryl Allergy Extra Strength Liqui-Gels	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	30aca3ab-b091-3939-e063-6294a90a9819	2025-12-03	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	L.N.K. International, Inc.	9f2daffc-1904-4d64-9f84-689c88601e06	2025-12-03	Warnings	Exact identifier application number: M012
Childrens Multi-symptom Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Wal-Mart Stores, Inc.	d291faa9-894e-421c-8115-8a8c2a937172	2025-12-03	Warnings	Exact identifier application number: M012
SINUS PAIN AND CONGESTION	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	CVS Pharmacy	697dffdd-5b56-4395-8e69-6b4360d9fdc5	2025-12-02	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores,Inc.,	9c8c1974-f931-4493-abb5-ecdc32764ab3	2025-12-02	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1086443	chlorpheniramine maleate 4 MG / dextromethorphan HBr 15 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution	PSN	e0e2b117-62bc-4132-9f7c-fe2a912052b1	10
1086443	chlorpheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 3 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution	SCD	e0e2b117-62bc-4132-9f7c-fe2a912052b1	10
1086443	chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral Solution	SY	e0e2b117-62bc-4132-9f7c-fe2a912052b1	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0485-0171-16	00485017116	473 mL in 1 BOTTLE, PLASTIC (0485-0171-16)	473 ml	2012-09-11	0000-00-00	No	No	Current