FDA.reportPublic FDA data

Dextromethorphan Hydrobromide

Product NDC
35916-0461
11-digit product format
359160461
Labeler code
35916
Product ID
35916-0461_5d533645-2151-6cae-e063-6394a90aaeaf
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Softgel Healthcare Pvt Ltd
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-11
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
15 mg/1
Pharmacologic classes
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
Dextromethorphan Hydrobromide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-0461-1Dextromethorphan Hydrobromide20 in 1 BOTTLECAPSULE, LIQUID FILLED205
35916-0461-2Dextromethorphan Hydrobromide1000 in 1 BAGCAPSULE, LIQUID FILLED10005
35916-0461-3Dextromethorphan Hydrobromide3000 in 1 POUCHCAPSULE, LIQUID FILLED30005
35916-0461-3Dextromethorphan Hydrobromide2 in 1 BOXCAPSULE, LIQUID FILLED25
35916-0461-4Dextromethorphan Hydrobromide2 in 1 BOXCAPSULE, LIQUID FILLED25
35916-0461-4Dextromethorphan Hydrobromide1500 in 1 BAGCAPSULE, LIQUID FILLED15005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35916-0461DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD]2Current NDC, 6 package rows20250321_20f7c1a9-fc4d-1f51-e063-6394a90a8be3.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 91 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TARGET CHILDRENs COLD and COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTARGET CORPORATIONeb912834-1b14-484d-90f7-a8deb52c0d4e2025-11-05WarningsExact identifier
application number: M012
UP and UP Daytime Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationa2d99bc8-7295-4922-acff-0cb02c91273c2025-11-05WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILAMERISOURCE BERGENc1843f1a-ae5b-0fdf-e053-2995a90aae382025-11-05WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)4754363d-e163-42e0-a65d-1c4bac24f6c92025-11-05WarningsExact identifier
application number: M012
Day Time Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLSafeway, Inc.76d62892-615d-4744-95aa-3be1207a0e572025-11-05WarningsExact identifier
application number: M012
Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINSafeway, Inc.6fefff08-13b0-47eb-aa32-8d7e4deeae7b2025-11-05WarningsExact identifier
application number: M012
Menthol Drops Freegells Extra Strong Eucalyptus 30ctMENTHOLR.L. ALBERT & SON, INC165a8efa-2b03-4329-99fa-3233f0af7d082025-11-04WarningsExact identifier
application number: M012
Menthol Drops Freegells Extra Strong Honey Lemon 30ctMENTHOLR.L. ALBERT & SON, INCf9ea46fc-0b04-444e-95fc-09aff7e7978a2025-11-04WarningsExact identifier
application number: M012
QUALITY CHOICE Maximum Strength Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.40413cdb-68ac-70e1-e063-6394a90a92172025-11-04WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLWinCo Foods, LLC73fec783-1594-447b-b059-49ea9dbb5bee2025-11-04WarningsExact identifier
application number: M012
Texaclear Fast Acting Allergy ReliefCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATEGM Pharmaceuticals, INC17a2f643-fa98-21ee-e054-00144ff88e882025-11-03WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e618bc7-0f51-e586-e063-6294a90afe372025-11-03WarningsExact identifier
application number: M012
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e61b5b3-ad15-01bf-e063-6394a90a6ec32025-11-03WarningsExact identifier
application number: M012
Cold plus Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC409540c0-1bab-9969-e063-6394a90a47c12025-11-03WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e60b340-bd60-9318-e063-6294a90ad0792025-11-03WarningsExact identifier
application number: M012
Sinus Pressure and Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e60e32f-3e5f-b775-e063-6294a90a097d2025-11-03WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e614265-b35a-5d01-e063-6294a90aad852025-11-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e60b0ed-889d-0f17-e063-6394a90a46942025-11-03WarningsExact identifier
application number: M012
VANACOF DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGM Pharmaceuticals, INC2ed699f2-d004-4fa9-8042-6c85a9ff69b62025-11-03WarningsExact identifier
application number: M012
Geri DrylDIPHENHYDRAMINE HCLVERITYRX, LLC42a05f69-0599-5571-e063-6394a90a37d32025-11-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090487dextromethorphan HBr 15 MG Oral CapsulePSN20f7c1a9-fc4d-1f51-e063-6394a90a8be35
1090487dextromethorphan hydrobromide 15 MG Oral CapsuleSCD20f7c1a9-fc4d-1f51-e063-6394a90a8be35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35916-0461-13591604610120 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-0461-1) 2024-09-11NoNoCurrent
35916-0461-2359160461021000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0461-2) 2025-03-18NoNoCurrent
35916-0461-3359160461032 POUCH in 1 BOX (35916-0461-3) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH2 pouch2025-07-17NoNoCurrent
35916-0461-4359160461042 BAG in 1 BOX (35916-0461-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG2 bag2026-01-12NoNoCurrent