NDC 0121-4809

Guaifenesin DM

Guaifenesin And Dextromethorphan

Guaifenesin DM is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is Guaifenesin; Dextromethorphan.

• Product ID: 0121-4809_58f894c7-263c-433a-af8d-7073c7079917
• NDC: 0121-4809
• Product Type: Human Otc Drug
• Proprietary Name: Guaifenesin DM
• Generic Name: Guaifenesin And Dextromethorphan
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2010-05-17
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Pharmaceutical Associates, Inc.
• Substance Name: GUAIFENESIN; DEXTROMETHORPHAN
• Active Ingredient Strength: 200 mg/5mL; mg/5mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 0121-4809-05

4 TRAY in 1 CASE (0121-4809-05) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE

• Marketing Start Date: 2010-05-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0121-4809-10 [00121480910]

Guaifenesin DM SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2010-05-17
• Inactivation Date: 2019-10-21

NDC 0121-4809-05 [00121480905]

Guaifenesin DM SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2010-05-17
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	200 mg/5mL

OpenFDA Data

• SPL SET ID: 990eef79-5380-48c6-8b8f-d4814e0fd293
• Manufacturer:
  • Pharmaceutical Associates, Inc.
• UNII:
  • 7355X3ROTS
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1046631

NDC Crossover Matching brand name "Guaifenesin DM" or generic name "Guaifenesin And Dextromethorphan"

NDC	Brand Name	Generic Name
0121-0638	GUAIFENESIN DM	GUAIFENESIN and DEXTROMETHORPHAN
0121-0809	Guaifenesin DM	GUAIFENESIN and DEXTROMETHORPHAN
0121-1276	GUAIFENESIN DM	GUAIFENESIN and DEXTROMETHORPHAN
0121-4809	Guaifenesin DM	GUAIFENESIN and DEXTROMETHORPHAN
43063-801	Guaifenesin DM	Guaifenesin and Dextromethorphan Hydrobromide
50090-2303	GUAIFENESIN DM	GUAIFENESIN and DEXTROMETHORPHAN
50090-3492	GUAIFENESIN DM	GUAIFENESIN and DEXTROMETHORPHAN
55154-5783	GUAIFENESIN DM	GUAIFENESIN and DEXTROMETHORPHAN
55154-5785	GUAIFENESIN DM	GUAIFENESIN and DEXTROMETHORPHAN
66007-204	Expectorant plus Cough Relief	Guaifenesin and Dextromethorphan
69822-021	MMM - Cough Formula Guaifenesin DM	Guaifenesin DM