FDA.reportPublic FDA data

DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN

Product NDC
85722-0002
11-digit product format
857220002
Labeler code
85722
Product ID
85722-0002_9cb5da4e-9175-4339-83da-fc22448b2e80
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Dosage form
SYRUP
Route
ORAL
Labeler
KJD Pharma Private Limited
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 300 mg/5mL; mg/5mL
Pharmacologic classes
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]
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 HYDROBROMIDE and GUAIFENESIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/5mL
GUAIFENESIN300 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1117394Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b109249a-a0be-41bd-b6ce-ef621b588ddcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85722-0002-4DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN118 mL in 1 BOTTLESYRUP1182
85722-0002-6DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN473 mL in 1 BOTTLESYRUP4732
85722-0002-8DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN236 mL in 1 BOTTLESYRUP2362

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 145 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter832eb36c-21c6-46d7-b1f8-ab8b6f1e501e2024-10-22WarningsExact identifier
application number: M012
Sinus plus HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEHarris Teeterc9d82968-b2ec-2f4b-e053-2a95a90a7f0c2024-10-22WarningsExact identifier
application number: M012
Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEHarris Teeterb9d9ab99-44b1-455f-a29a-95c193a4808e2024-10-22WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHARRIS TEETERb96c376e-578f-1124-e053-2a95a90acbb42024-10-22WarningsExact identifier
application number: M012
Tukol Honey Daytime and Nighttime Value PackACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEGenomma Lab USAbccc11d2-d227-4cbb-b0fc-ac6abb6dce572024-10-22WarningsExact identifier
application number: M012
Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHarris Teeterc92b508b-e5f9-4149-8c4b-d21845943b3b2024-10-22WarningsExact identifier
application number: M012
Cold Flu Severe Day NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHarris Teeter2924a691-b352-4263-b6ba-9ab97e95e2a52024-10-22WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHARRIS TEETERb2091281-a64a-190a-e053-2995a90a890a2024-10-22WarningsExact identifier
application number: M012
tussinDEXTROMETHORPHAN HBR, GUAIFENESINSafewaycf04bdf7-fed4-4f06-a193-f2e83fcc531c2024-10-22WarningsExact identifier
application number: M012
Tukol Honey Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAc9572b16-8e28-4f98-bd87-8a07721a49c62024-10-21WarningsExact identifier
application number: M012
Tukol Honey Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEGenomma Lab USAbf25f38e-3549-4f78-be90-46605b5f2c112024-10-21WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHEBb5a6719e-746b-58ec-e053-2a95a90af0102024-10-21WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEHEBa6cdc084-c23b-e733-e053-2995a90a35062024-10-21WarningsExact identifier
application number: M012
Cold Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBea39a67d-8a99-4f7c-9925-94b07d0b10922024-10-21WarningsExact identifier
application number: M012
Head Congestion plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBeb7920a3-3c25-6aa1-e053-2995a90ac2b92024-10-21WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEB9cbb3ab1-5f32-421e-9f28-d99be9447e9f2024-10-21WarningsExact identifier
application number: M012
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBeb791902-e2c3-5662-e053-2995a90a37fd2024-10-21WarningsExact identifier
application number: M012
Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBc3849b66-697f-4f6e-93ab-76de031b3c702024-10-21WarningsExact identifier
application number: M012
Cold Flu Severe Day NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBee1477ed-00c4-46ea-bc57-aef214076dc22024-10-21WarningsExact identifier
application number: M012
DAYTIME SEVERE COLD AND FLU MAXIMUM STRENGTHACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEB774e8bee-1ab5-4587-82e4-31da8ec835442024-10-21WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1117394dextromethorphan HBr 20 MG / guaiFENesin 300 MG in 5 mL Oral SolutionPSNb109249a-a0be-41bd-b6ce-ef621b588ddc2
1117394dextromethorphan hydrobromide 4 MG/ML / guaifenesin 60 MG/ML Oral SolutionSCDb109249a-a0be-41bd-b6ce-ef621b588ddc2
1117394dextromethorphan hydrobromide 20 MG / guaifenesin 300 MG per 5 ML Oral SolutionSYb109249a-a0be-41bd-b6ce-ef621b588ddc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85722-0002-485722000204118 mL in 1 BOTTLE (85722-0002-4) 118 ml2021-02-01NoNoCurrent
85722-0002-685722000206473 mL in 1 BOTTLE (85722-0002-6) 473 ml2021-02-01NoNoCurrent
85722-0002-885722000208236 mL in 1 BOTTLE (85722-0002-8) 236 ml2021-02-01NoNoCurrent