G-SUPRESS DX PEDIATRIC DROPS

Product NDC
52083-651
11-digit product format
520830651
Labeler code
52083
Product ID
52083-651_415366fa-2a35-40e2-927d-8ed94cde28e6
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Kramer Novis
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-10-06
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5; 50; 2.5 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
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
G-SUPRESS DX PEDIATRIC DROPS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/mL
GUAIFENESIN50 mg/mL
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/mL

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 97 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough Drops Dollar General Honey Lemon 200ctMENTHOLDollar General Corporationf85f1a15-db7f-4bb5-9313-24702660054e2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 30ctMENTHOLDollar General Corporation61a23ce6-5157-4076-afa7-6a79c62fe9e02025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 30ctMENTHOLDollar General Corporationd5fb7d9e-b0f6-4424-bf67-9e72b50366b12025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 160ctMENTHOLDollar General Corporation9f9916f5-83ea-4f36-b8c2-c6fe1f77884b2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 80ctMENTHOLDollar General Corporationa23ec89a-de7e-4013-b85b-1593e18dc28e2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 160ctMENTHOLDollar General Corporation1833d3bf-6f01-4122-9f4d-4d8b2423fcbb2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 30ctMENTHOLDollar General Corporationfbe92e39-6470-4634-b976-e316baa2c9952025-10-08WarningsExact identifier
application number: M012
EquateVAPORIZING STEAM LIQUIDWalmart Inc.ffede19a-06e2-61c7-e053-6394a90ac77b2025-10-08WarningsExact identifier
application number: M012
Menthol Drops Dollar General Severe Honey Lemon 45ctMENTHOLDollar General Corporation0ea61a4c-690a-4349-9952-cc17fb1f06712025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 30ctMENTHOLDollar General Corporation892092cc-5a1c-4309-baf9-a040888d35772025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 80ctMENTHOLDollar General Corporation773f4ad2-6c91-431f-ad3d-c0e53e7ca9182025-10-08WarningsExact identifier
application number: M012
Menthol Drops Dollar General Severe 45ctMENTHOLDollar General Corporation13c7d3b1-12ac-4931-877c-728d3d89942c2025-10-08WarningsExact identifier
application number: M012
Menthol Drops Dollar General Severe Honey Lemon 45ctMENTHOLDollar General Corporationd0c878f0-a737-4583-9847-834af70e7d6f2025-10-08WarningsExact identifier
application number: M012
Cough Drops Freegells Strawberry 30ctMENTHOLR.L. ALBERT & SON, INCdc077c36-c403-4b83-894a-e9922e9288412025-10-08WarningsExact identifier
application number: M012
Cough Drops Freegells Strawberry 30ctMENTHOLRL Albert & Son Inc.2ea760f3-df50-4c46-a43d-d5ed07f421a52025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Honey Lemon 200ctMENTHOLRL Albert & Son Inc.3ac08274-08d9-4dab-b09a-6e297948a25a2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Honey Lemon 30ctMENTHOLRL Albert & Son Inc.8114e1a2-728d-4489-a494-f28a5e7d9bb32025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol 30ctMENTHOLRL Albert & Son Inc.0c2e594a-cdf8-4595-bda6-0ebc19ac38502025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 200ctMENTHOLR.L. ALBERT & SON, INCf62b7f75-3275-46c9-880c-64148d0dce592025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol 80ctMENTHOLR.L. ALBERT & SON, INC15917bfb-f660-4a12-bdcc-5b4a96e0e1d02025-10-08WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52083-651-01520830651011 BOTTLE in 1 CARTON (52083-651-01) / 30 mL in 1 BOTTLE1 bottle2026-10-06NoNoCurrent