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 65 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QUALITY CHOICECOUGH DROPS VITAMIN CXiamen Kang Zhongyuan Biotechnology Co., Ltd.23086723-5718-6d02-e063-6394a90a03d22025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Creamy StrawberryCOUGH DROPS CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23085717-b2ee-175c-e063-6394a90a7f542025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS MENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2307bbe9-7c8f-4eff-e063-6394a90af4c32025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2de803-900d-02f4-e063-6394a90a84cc2025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS HONEY LEMON SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.2307f3a7-f6e7-8a5d-e063-6394a90ab7eb2025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS MENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2e8fbe-c1c3-79b1-e063-6394a90a4d732025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS HONEY LEMONXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2dfcc3-e599-3102-e063-6394a90ad54a2025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS BLACK CHERRY SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2ead3c-b4d5-ee8f-e063-6294a90a3c392025-12-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f42644-045b-c4b3-e063-6294a90a48fd2025-12-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS VANILLA HONEYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f45499-bf14-03e4-e063-6394a90a535c2025-12-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS BLACK CHERRY SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f3ddcc-9d4e-f1b1-e063-6294a90ac86f2025-12-29WarningsExact identifier
application number: M012
Menthol Flavor Cough DropMENTHOL FLAVOR COUGH DROPXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a5551-4989-d8fe-e063-6394a90aeabf2025-12-29WarningsExact identifier
application number: M012
MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough DropsMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f2acaa-2cc8-a999-e063-6294a90a15ce2025-12-29WarningsExact identifier
application number: M012
Leader Throat Soothing Drops Creamy StrawberryTHROAT SOOTHING CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a92ecc-6a9c-b569-e063-6394a90a8bcb2025-12-29WarningsExact identifier
application number: M012
ValuMeds Allergy Relief Antihistamine Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.a5ceab90-6885-4f3a-b001-97679e03c01b2025-12-29WarningsExact identifier
application number: M012
Goodmeds Non-Drowsy Cough ReliefDEXTROMETHORPHAN HYDROBROMIDECabinet Health P.B.C.32482083-3f51-41f4-8d20-bedf143e066d2025-12-29WarningsExact identifier
application number: M012
Tusnel EXGUAIFENESINLlorens Pharmaceutical International Division, Inc.77c16288-68c4-476c-995f-86f5056632702025-12-29WarningsExact identifier
application number: M012
Tusnel DMDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLLlorens Pharmaceutical International Division, Inc.fe457e6d-422d-496c-bcb9-33594f3c42ff2025-12-29WarningsExact identifier
application number: M012
Tusnel DiabeticDEXTROMETHORPHAN, GUAIFENESINLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION66b3c094-809e-4d2c-bc15-46563de685cb2025-12-29WarningsExact identifier
application number: M012
FortifyMENTHOLNatures Formulae Health Products Ltd.781d53cf-b3dc-3e2b-e053-2a91aa0a7dcd2025-12-29WarningsExact 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