NDC 57344-136

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Aaa Pharmaceutical, Inc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 57344-136_8ffe8753-299d-46e2-a967-d7d1512bba2a
• NDC: 57344-136
• Product Type: Human Otc Drug
• Proprietary Name: Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-12-28
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: AAA Pharmaceutical, Inc.
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 57344-136-02

2 BLISTER PACK in 1 CARTON (57344-136-02) > 12 TABLET, COATED in 1 BLISTER PACK

• Marketing Start Date: 2012-12-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57344-136-02 [57344013602]

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, COATED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-08-02
• Marketing End Date: 2017-10-31

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 1daf432e-3f21-4a30-909e-094fe39cc3a4
• Manufacturer:
  • AAA Pharmaceutical, Inc.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1110988

NDC Crossover Matching brand name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
57344-159	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
57344-134	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
57344-163	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
57344-136	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
0280-0921	Alka-Seltzer Plus Day Severe Cold Plus Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
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
36800-502	COLD AND FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and 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
36800-474	Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
11822-1576	Maximum Strength Severe Sinus Pressure, Pain and Cough Relief	Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, 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
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
15127-184	Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
0363-4150	Severe Cold and Flu 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
36800-747	Topcare Mucus Relief	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
0363-6300	Walgreen Severe Multi-Symptom Cough Cold Flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
0363-8591	Walgreens Severe Cold Multi-Symptom For Adults	acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride