NDC 0485-0240

ED-A-HIST DM

Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

ED-A-HIST DM is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Edwards Pharmaceuticals, Inc.. The primary component is Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

• Product ID: 0485-0240_0b56f57d-6a1b-4c9a-b28b-0fca8064c739
• NDC: 0485-0240
• Product Type: Human Otc Drug
• Proprietary Name: ED-A-HIST DM
• Generic Name: Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-10-27
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: EDWARDS PHARMACEUTICALS, INC.
• Substance Name: CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 4 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0485-0240-01

100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0240-01)

• Marketing Start Date: 2014-10-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0485-0240-01 [00485024001]

ED-A-HIST DM TABLET, COATED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-10-27
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-04-08

Drug Details

Active Ingredients

Ingredient	Strength
CHLORPHENIRAMINE MALEATE	4 mg/1

OpenFDA Data

• SPL SET ID: 07cd07a1-d84c-4a91-8fa6-5eb58dd23991
• Manufacturer:
  • EDWARDS PHARMACEUTICALS, INC.
• UNII:
  • V1Q0O9OJ9Z
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1593105
• UPC Code:
  • 0304850240013

NDC Crossover Matching brand name "ED-A-HIST DM" or generic name "Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
0485-0240	ED-A-HIST DM	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
66576-240	ED-A-HIST DM	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
53809-202	DOMETUSS	chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride
58605-103	Maxichlor PEH DM	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE