NDC 48201-009

Calmadol Plus

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

Calmadol Plus is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Grandall Distributing Co., Inc.. The primary component is Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

• Product ID: 48201-009_356a1a6a-76b8-0285-e054-00144ff88e88
• NDC: 48201-009
• Product Type: Human Otc Drug
• Proprietary Name: Calmadol Plus
• Generic Name: Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
• Dosage Form: Liquid
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-06-16
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Grandall Distributing Co., Inc.
• Substance Name: ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 160 mg/5mL; mg/5mL; mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 48201-009-01

1 BOTTLE in 1 BOX (48201-009-01) > 118 mL in 1 BOTTLE

• Marketing Start Date: 2016-06-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 48201-009-01 [48201000901]

Calmadol Plus LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-06-16

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL

OpenFDA Data

• SPL SET ID: 998cf528-5993-4493-b080-5e2c4ac0a411
• Manufacturer:
  • Grandall Distributing Co., Inc.
• UNII:
  • V1Q0O9OJ9Z
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1113397

NDC Crossover Matching brand name "Calmadol Plus" or generic name "Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
48201-009	Calmadol Plus	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
0280-1212	Alka-Seltzer Plus Maximum Strength Cold and Cough	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
0280-0023	Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz	acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
0280-1560	Alka-Seltzer Plus Severe Cold and Flu	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
56062-239	childrens cold and flu	acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
63868-374	Childrens Multi-Symptom Cold Plus	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
0363-0034	Childrens Plus Multi Symptom Cold	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
11822-5047	Childrens Plus Multi Symptom Cold	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
15127-931	Childrens Plus Multi Symptom Cold	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
21130-034	Childrens Plus Multi Symptom Cold	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
41520-704	Childrens Plus Multi Symptom Cold	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
46122-310	Childrens Plus Multi Symptom Cold	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
55315-304	Childrens Plus Multi Symptom Cold	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
55910-043	Childrens Plus Multi Symptom Cold	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
51467-007	COLTALIN-DM	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
55910-014	DG Health cold multi symptom	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
58552-137	Giltuss Childrens MultiSymptom Cold and Flu	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
58552-136	Giltuss MultiSymptom Cold and Flu	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
48201-001	Sanaflu Xtra	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
49873-114	Stona	acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
49873-113	Stona-S	acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
36800-809	topcare childrens cold and flu	acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride