FDA.reportPublic FDA data

Cough Relief

Product NDC
63868-957
11-digit product format
638680957
Labeler code
63868
Product ID
63868-957_d605db56-e99e-4de8-9c3f-8107dab1394c
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
LIQUID
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-07-31
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
15 mg/5mL
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
Cough Relief
Brand name suffix
Cough Suppressant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/5mL

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
1090496Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
13ae4c67-a3fe-440c-91b8-c9412626c3cdAvailable 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-957-04Cough ReliefCough Suppressant118 mL in 1 BOTTLE, PLASTICLIQUID1186
63868-957-04Cough ReliefCough Suppressant1 in 1 BOXLIQUID16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-957-04ML - Milliliter63868-957156ddc12-da60-4d9d-a7c5-cdba23c942a712022-03-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOUGH RELIEF COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOUGH RELIEF COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCOUGH RELIEF COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCOUGH RELIEF COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8COUGH RELIEF COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOUGH RELIEF COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCOUGH RELIEF COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)INACTIVE INGREDIENTL605B5892VCOUGH RELIEF COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACOUGH RELIEF COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COUGH RELIEF COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCOUGH RELIEF COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4COUGH RELIEF COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SUCROSEINACTIVE INGREDIENTC151H8M554COUGH RELIEF COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
WATERINACTIVE INGREDIENT059QF0KO0RCOUGH RELIEF COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOUGH RELIEF COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-957COUGH RELIEF COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]6Current NDC, Legacy NDC, 2 package rows20240423_13ae4c67-a3fe-440c-91b8-c9412626c3cd.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 108 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
meijer Nighttime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.377248b6-d64d-8dff-e063-6394a90a43f62025-07-31WarningsExact identifier
application number: M012
meijer Daytime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.3771f778-7ac9-7108-e063-6394a90a11052025-07-31WarningsExact identifier
application number: M012
tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINCVS Pharmacy087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca2025-07-31WarningsExact identifier
application number: M012
Equate NasalOXYMETAZOLINE HCLWal-Mart Stores Incc38a2783-aed9-466d-8976-59d03a792c042025-07-30WarningsExact identifier
application number: M012
Quality Choice Throat Soothing Drops Creamy StrawberryPECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.3b15d2ea-f784-275d-e063-6394a90a800c2025-07-29WarningsExact identifier
application number: M012
Respiratory ReliefGUAIFENESINSchwabe North America, Incf683041a-4ff9-42a5-9047-a9a3140a87582025-07-29WarningsExact identifier
application number: M012
Childrens Robitussin Honey Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCb87f700e-3414-463c-80d4-c3dbca89a4882025-07-29WarningsExact identifier
application number: M012
Tussin DMTUSSIN DMAllegiant Health7a2f8d48-3123-4c37-b238-bd7cc4242bb72025-07-23WarningsExact identifier
application number: M012
Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Inc5fb2438b-8f2d-4af2-9981-42d278d268002025-07-23WarningsExact identifier
application number: M012
DR. SANA COUGH AND CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Incbaca0580-4c30-4b94-89fa-a7cf06d4ff252025-07-22WarningsExact identifier
application number: M012
Defensol DACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCIMenper Distributors, Inc.f466c660-69eb-4581-81ff-1499fa421d8b2025-07-22WarningsExact identifier
application number: M012
Defensol D Blister PackACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCIMenper Distributors, Inc.0dfcc977-6101-4536-e063-6294a90a7a482025-07-22WarningsExact identifier
application number: M012
BroncofinDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMenper Distributors, Inc.fdf67382-1692-485b-92f1-2cbb8be4fb702025-07-22WarningsExact identifier
application number: M012
Defensol Adult SyrupGUAIFENESIN, DEXTROMETHORPHAN HBRMenper Distributors, Inc.62acff69-8c40-4a0e-8d56-be2cc14e3d452025-07-22WarningsExact identifier
application number: M012
Cosedal DropsDEXTROMETHORPHAN HBR, GUAIFENESINMenper Distributors, Inc.1241d249-ea3b-4d2b-87ed-835d6a2d286a2025-07-22WarningsExact identifier
application number: M012
Berro y Cebolla DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMenper Distributors, Inc.20107bd9-6d84-4ab5-a0d9-966f1f11d9192025-07-22WarningsExact identifier
application number: M012
Defensol-itoDEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINEMenper Distributors, Inca7c7a60d-d49f-4239-92f7-714eac7eb0c52025-07-22WarningsExact identifier
application number: M012
Bisolvine ChildrenGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.896a5443-e3d2-4af7-9e27-f1c1899ce0382025-07-22WarningsExact identifier
application number: M012
Bisolvine Aloe-MielDEXTROMETHORPHAN, GUAIFENESINMENPER DISTRIBUTORS INC.34801c79-ce88-492f-808e-b639e86016072025-07-22WarningsExact identifier
application number: M012
Viva Porru Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILMenper Distributors, Inc.0dfadfe3-9e40-0eee-e063-6294a90a00c32025-07-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090496dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSN13ae4c67-a3fe-440c-91b8-c9412626c3cd6
1090496dextromethorphan hydrobromide 3 MG/ML Oral SolutionSCD13ae4c67-a3fe-440c-91b8-c9412626c3cd6
1090496dextromethorphan hydrobromide 15 MG per 5 ML Oral SolutionSY13ae4c67-a3fe-440c-91b8-c9412626c3cd6
1090496dextromethorphan hydrobromide 30 MG per 10 ML Oral SolutionSY13ae4c67-a3fe-440c-91b8-c9412626c3cd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-957-04638680957041 BOTTLE, PLASTIC in 1 BOX (63868-957-04) / 118 mL in 1 BOTTLE, PLASTIC2015-07-310000-00-00NoNoCurrent