NDC 56062-197

Cold Flu and Sore Throat

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Cold Flu and Sore Throat is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Publix Super Markets Inc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 56062-197_9467cc12-0e8d-06a4-e053-2a95a90a6eba
• NDC: 56062-197
• Product Type: Human Otc Drug
• Proprietary Name: Cold Flu and Sore Throat
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-09-13
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: PUBLIX SUPER MARKETS INC
• 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 56062-197-02

2 BLISTER PACK in 1 CARTON (56062-197-02) > 10 TABLET, COATED in 1 BLISTER PACK

• Marketing Start Date: 2019-09-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 56062-197-02 [56062019702]

Cold Flu and Sore Throat TABLET, COATED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-09-13

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 68a5930b-37db-439d-8fb9-7d7de07d8465
• Manufacturer:
  • PUBLIX SUPER MARKETS INC
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1110988
• UPC Code:
  • 0041415440739

NDC Crossover Matching brand name "Cold Flu and Sore Throat" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
0363-1209	Cold Flu and Sore Throat	Acetaminophen, Dextromethporphan HBr, Guaifenesin, Phenylephrine HCl
69842-205	cold flu and sore throat	cold flu and sore throat
41250-381	cold flu and sore throat	cold flu and sore throat
56062-197	Cold Flu and Sore Throat	Cold Flu and Sore Throat
72476-197	COLD FLU AND SORE THROAT	COLD FLU AND SORE THROAT
0280-0921	Alka-Seltzer Plus Day Severe Cold Plus Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-502	COLD AND FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-986	Cold and Flu Severe Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37000-524	DayQuil Severe plus Vicks VapoCool	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
37808-178	DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-474	Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-298	Mucus Relief Cold and Flu All In One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-697	Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-764	Mucus Relief Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37808-164	Mucus Relief Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37808-079	Mucus Relief Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-775	Pressure Plus Pain PE Plus Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
15127-184	Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37000-810	Vicks DayQuil	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
37000-811	Vicks DayQuil	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
0363-8591	Walgreens Severe Cold Multi-Symptom For Adults	acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride