FDA.reportPublic FDA data

Pharbinex-DM

Product NDC
73057-381
11-digit product format
730570381
Labeler code
73057
Product ID
73057-381_2c2a50d1-d024-3c0f-e063-6394a90a13cc
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin 400mg and Dextromethorphan HBr 20mg
Dosage form
TABLET
Route
ORAL
Labeler
Ulai Health LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-18
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
400; 20 mg/1; mg/1
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73057-381-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73057-381-040efc9e666f02…f202fb6c5f17…

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
Pharbinex-DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 mg/1
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1147685Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
af80d10e-3fb2-405a-a803-1f876b8dcd10Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73057-381-042022-01-31C16284748780-1d6a99b39-5068-a426-e053-dadaa90af4c2Drug Facts
73057-381-042022-01-28C16284748780-1d6a99b39-5068-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73057-381-04Pharbinex-DM30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73057-381PHARBINEX-DM (GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG) TABLET [ULAI HEALTH LLC]3Current NDC, Legacy NDC, 1 package rows20250122_af80d10e-3fb2-405a-a803-1f876b8dcd10.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 93 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEVERITYRX, LLC42a0e577-a1b6-2c16-e063-6294a90af8e32025-11-02WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corpc296efd0-5030-4a26-a9b0-e66423d995dc2025-10-31WarningsExact identifier
application number: M012
Daytime Cold and Flu Max Maximum Strength SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTopco Associates, LLCf7ebe482-cb22-4517-8463-3432cf60071d2025-10-31WarningsExact identifier
application number: M012
Nighttime Cold and Flu Max SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates, LLC787bff76-0ee2-4e7e-b908-876e4a3e3bfc2025-10-31WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLTrader Joe's Company647dadae-f37a-8399-e053-2991aa0aedb32025-10-31WarningsExact identifier
application number: M012
Family Care SalineSODIUM CHLORIDEUnited Exchange Corp.06737393-d4ae-3e7b-e063-6394a90ac19f2025-10-31WarningsExact identifier
application number: M012
QUALITY CHOICE Maximum Strength Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.40416ff5-06e1-97dd-e063-6394a90a20462025-10-30WarningsExact identifier
application number: M012
Robitussin Maximum Strength Nighttime Cough DMDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHaleon US Holdings LLC44feee2f-25bc-48d4-8e13-db1d9daaaa902025-10-30WarningsExact identifier
application number: M012
Robitussin Day and Night Cough Relief DM MaxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCb3d02c91-8f79-4eb4-a378-1072474c572c2025-10-30WarningsExact identifier
application number: M012
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCf1d022dd-c2ca-497f-87d5-9ef3e20e8ea72025-10-30WarningsExact identifier
application number: M012
EndalTRIPROLIDINE HCL, DEXTROMETHORPHAN HBRPoly Pharmaceuticals, Inc.fc5401e2-ed65-72e7-e053-6294a90a81f32025-10-30WarningsExact identifier
application number: M012
daytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPublix Super Markets Incc7cef266-46fc-49ab-a2e7-54fc562986592025-10-30WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDESAM'S WEST INC16592ad7-b7cb-0837-e063-6394a90ae0592025-10-29WarningsExact identifier
application number: M012
Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCLSAFEWAY013b94a1-26c7-4371-981a-d1b9d7fd1c982025-10-29WarningsExact identifier
application number: M012
Better LivingPHENYLEPHRINE HYDROCHLORIDEBETTER LIVING BRANDS LLCaea0db7f-e01a-4d8e-9c20-4a5ef4a905d12025-10-29WarningsExact identifier
application number: M012
AXIM DayTime - Night Time 72 SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEVIVUNT PHARMA LLCde9eb2d5-ba51-4637-e053-2995a90a04512025-10-29WarningsExact identifier
application number: M012
Dollar General Vapor SteamCAMPHOR (SYNTHETIC)DOLGENCORP, LLC86d0f3ac-1359-c2f9-e053-2a91aa0a35d02025-10-29WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLStrategic Sourcing Services LLC5d628b09-c257-4369-8ddb-47554d83c0d82025-10-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSNaf80d10e-3fb2-405a-a803-1f876b8dcd103
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCDaf80d10e-3fb2-405a-a803-1f876b8dcd103
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSYaf80d10e-3fb2-405a-a803-1f876b8dcd103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73057-381-047305703810430 TABLET in 1 BOTTLE, PLASTIC (73057-381-04) 30 tablet2019-07-180000-00-00NoNoCurrent