FDA.reportPublic FDA data

Dextromethorphan HBr 15 mg

Product NDC
53345-011
11-digit product format
533450011
Labeler code
53345
Product ID
53345-011_2767cee1-e298-26d6-e063-6294a90ab8b8
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-30
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
2026-12-31
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 HBr 15 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1090487Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
028b025e-2dde-4bef-ba7b-61774e855b4bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
53345-011-01Dextromethorphan HBr 15 mg12000 in 1 BAGCAPSULE, LIQUID FILLED120003
53345-011-01Dextromethorphan HBr 15 mg1 in 1 BOXCAPSULE, LIQUID FILLED13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDEXTROMETHORPHAN HBR 15 MG (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDEXTROMETHORPHAN HBR 15 MG (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDEXTROMETHORPHAN HBR 15 MG (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADEXTROMETHORPHAN HBR 15 MG (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
GELATININACTIVE INGREDIENT2G86QN327LDEXTROMETHORPHAN HBR 15 MG (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDEXTROMETHORPHAN HBR 15 MG (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDEXTROMETHORPHAN HBR 15 MG (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EDEXTROMETHORPHAN HBR 15 MG (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DEXTROMETHORPHAN HBR 15 MG (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
SORBITOLINACTIVE INGREDIENT506T60A25RDEXTROMETHORPHAN HBR 15 MG (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RDEXTROMETHORPHAN HBR 15 MG (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53345-011DEXTROMETHORPHAN HBR 15 MG (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]3Current NDC, Legacy NDC, 2 package rows20241122_028b025e-2dde-4bef-ba7b-61774e855b4b.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 97 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GILTUSS DIABETIC DMDEXTROMETHORPHAN HBRGil Pharmaceutical Corpbd367ce1-996b-45bc-865e-b6aafe0ea7b02025-10-09WarningsExact identifier
application number: M012
Giltuss DMDEXTROMETHORPHAN HBRGil Pharmaceutical Corp1a4fe686-3085-4543-bd6c-f20580b1df502025-10-09WarningsExact identifier
application number: M012
Giltuss D Allergy and CongestionCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLGil Pharmaceutical Corp8591003c-c2ec-df65-e053-2a91aa0a42fb2025-10-09WarningsExact identifier
application number: M012
GilphexGUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp.e7c8fb97-02cf-4df6-b477-9ff69d6b675d2025-10-09WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationd9f26677-ddef-4098-b564-9aa5734e088b2025-10-09WarningsExact identifier
application number: M012
Kalaya Breathe Easy Vaporizing RubVAPORIZING RUBAvaria Health & Beauty Corp7adf96b1-03af-a87b-e053-2a91aa0a45852025-10-08WarningsExact identifier
application number: M012
Equate RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalmart Inc01e1f418-c232-e89e-e063-6294a90abd352025-10-08WarningsExact identifier
application number: M012
EquateOXYMETAZOLINE HCLWalmart Inc020942b1-59d4-a19d-e063-6394a90a5d872025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Assorted Flavors 80ctMENTHOLDollar General425d2e63-f5bc-45fb-b330-967ae64cfddb2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Cherry 200ctMENTHOLDollar General Corporationa17aece2-abd8-452a-9da8-2e303845900b2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Cherry 30ctMENTHOLDollar General Corporationb96268da-d6f2-41e4-ba04-ce419376f6262025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Cherry 30ctMENTHOLDollar General Corporation51ccf39a-ae9b-4e6a-856c-002c296f5d072025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 200ctMENTHOLDollar General Corporation8f8a9474-f388-4ede-85f2-86222b15ee582025-10-08WarningsExact identifier
application number: M012
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090487dextromethorphan HBr 15 MG Oral CapsulePSN028b025e-2dde-4bef-ba7b-61774e855b4b3
1090487dextromethorphan hydrobromide 15 MG Oral CapsuleSCD028b025e-2dde-4bef-ba7b-61774e855b4b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53345-011-01533450011011 BAG in 1 BOX (53345-011-01) / 12000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2014-01-300000-00-00NoNoCurrent