Home NDC 21130-385 Adult Cough and Chest Congestion Relief DM
Product NDC 21130-385
11-digit product format 211300385
Labeler code 21130
Product ID 21130-385_2409db7e-fb17-4b06-b55a-3f3036dd0f54
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler Safeway, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-06-30
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20; 200 mg/10mL; mg/10mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Adult Cough and Chest Congestion Relief DM
Brand name suffix Non Drowsy
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/10mL GUAIFENESIN 200 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996520 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 21130-385-04 Adult Cough and Chest Congestion Relief DMNon Drowsy 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 13 21130-385-04 Adult Cough and Chest Congestion Relief DMNon Drowsy 1 in 1 BOX LIQUID 1 13 21130-385-08 Adult Cough and Chest Congestion Relief DMNon Drowsy 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 13 21130-385-08 Adult Cough and Chest Congestion Relief DMNon Drowsy 1 in 1 BOX LIQUID 1 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.] 3 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.] 3 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.] 3 GUAIFENESIN ACTIVE MOIETY 495W7451VQ ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.] 3 GLUCOSE OXIDASE INACTIVE INGREDIENT 0T8392U5N1 ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.] 3 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.] 3 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.] 3 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21130-385 ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.] 11 Current NDC, Legacy NDC, 4 package rows 20241105_5bd508a0-2f75-413e-a690-bed970131bef.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 21130-385-04 21130038504 1 BOTTLE, PLASTIC in 1 BOX (21130-385-04) / 118 mL in 1 BOTTLE, PLASTIC 2014-06-30 0000-00-00 No No Current 21130-385-08 21130038508 1 BOTTLE, PLASTIC in 1 BOX (21130-385-08) / 237 mL in 1 BOTTLE, PLASTIC 2014-06-30 0000-00-00 No No Current