NDC 55316-013

cold, flu and sore throat

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

cold, flu and sore throat is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Dza Brands Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 55316-013_46ea1549-99e4-4eb8-922a-844768c7ab78
• NDC: 55316-013
• Product Type: Human Otc Drug
• Proprietary Name: cold, flu and sore throat
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2017-03-08
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: DZA Brands LLC
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55316-013-14

2 BLISTER PACK in 1 CARTON (55316-013-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

• Marketing Start Date: 2017-03-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55316-013-14 [55316001314]

cold, flu and sore throat CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-03-08

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 028062ea-5072-45c1-80f0-e291d94b4dbe
• Manufacturer:
  • DZA Brands LLC
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1656815

NDC Crossover Matching brand name "cold, flu and sore throat" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
0363-1171	COLD, Flu and Sore Throat	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
0363-9016	COLD, Flu and Sore Throat	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
51013-197	cold, flu and sore throat	cold, flu and sore throat
55316-013	cold, flu and sore throat	cold, flu and sore throat
0280-0061	Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
0280-0507	Alka-Seltzer Plus Severe Sinus Cold and Cough	Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
0113-7902	basic care daytime cold and flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
0363-4661	Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
0363-9974	Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
41520-984	COLD FLU and SORE THROAT RELIEF	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
41250-327	Cold, Flu, and Sore Throat	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
41250-569	daytime cold and flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
37808-796	daytime severe	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
24385-066	good neighbor pharmacy cold	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
0113-4500	good sense sever day time cold and flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
47682-006	Green Guard Cough and Cold Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
11822-1576	Maximum Strength Severe Sinus Pressure, Pain and Cough Relief	Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
0031-8751	Robitussin Severe Multi-Symptom Cough Cold Flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
0363-1940	severe cold and flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
0363-4150	Severe Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
41520-985	Severe sinus Congestion Relief	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
11822-0940	severe vapor ice cold and flu relief	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
21130-811	signature care daytime severe cold and flu relief	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
36800-581	topcare day time cold and flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
36800-948	topcare day time cold and flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
36800-747	Topcare Mucus Relief	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
36800-842	topcare mucus relief cold and flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
0363-6300	Walgreen Severe Multi-Symptom Cough Cold Flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride