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 57 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens NightTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEWALGREEN COMPANY5bf72e2f-15c8-466a-9e13-50654233da912026-01-19WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreens9862f84d-1c18-4ef7-86dc-98572599d4172026-01-19WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWalgreens37853689-c9ca-4bc7-9c5b-4a68b8d778be2026-01-19WarningsExact identifier
application number: M012
VAPORXCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLAKRON PHARMA INC51b32162-0c5a-4b5b-999a-34337d8166032026-01-19WarningsExact identifier
application number: M012
EquateOXYMETAZOLINE HCLWalmart Inc2f762c24-2442-506a-e063-6394a90a3b962026-01-19WarningsExact identifier
application number: M012
DimetaneDIPHENHYDRAMINE HYDROCHLORIDERising Pharma Holdings, Inc.484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f2026-01-19WarningsExact identifier
application number: M012
nitetimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Incf681d986-9838-42d8-8ed9-732a39fbf8702026-01-19WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLH E B22d241c5-a3fd-4619-8147-91d7a4c8cf982026-01-19WarningsExact identifier
application number: M012
Nasal Decongestant Maximum StrengthPSEUDOEPHEDRINE HCLBetter Living Brands, LLC9fe63ca6-3863-4175-9aec-ecd6ebbdb2492026-01-19WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerisource Bergen5749ce9d-e182-478f-ab88-b520a35a99a72026-01-19WarningsExact identifier
application number: M012
Foster and Thrive Daytime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEStrategic Sourcing Services LLC1d9150b1-2f6c-4c33-8c93-3ed1d88585e22026-01-18WarningsExact identifier
application number: M012
HealthWise Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcarece3ceffd-3ff5-3795-e053-2995a90a827f2026-01-18WarningsExact identifier
application number: M012
topcare nite time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETopco Associates LLC31210a95-f9dc-49db-aab5-25c4dca492662026-01-17WarningsExact identifier
application number: M012
Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus CongestionACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLProcter & Gamble Manufactura S de RL de CVf77226c0-b6d5-9fd0-e053-6294a90a4b572026-01-16WarningsExact identifier
application number: M012
Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus CongestionACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLProcter & Gamble Manufactura S de RL de CVf691734b-5cf4-6eb8-e053-2a95a90aee802026-01-16WarningsExact identifier
application number: M012
Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus CongestionACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLProcter & Gamble Manufactura S de RL de CVf771aa19-295a-9f4e-e053-6294a90a16742026-01-16WarningsExact identifier
application number: M012
CVS Cherry Cough DropsMENTHOLCVS Pharmacyde5c4b94-0420-5d43-e053-2995a90aa5a52026-01-16WarningsExact identifier
application number: M012
CVS Honey Lemon Cough DropsMENTHOLCVS Pharmacyde963dc3-8108-440f-e053-2995a90a906f2026-01-16WarningsExact identifier
application number: M012
CVS SF Menthol Cough DropsMENTHOLCVS Pharmacye08f8ca3-b683-4964-e053-2a95a90afabb2026-01-16WarningsExact identifier
application number: M012
CVS SF Honey Lemon Cough DropsMENTHOLCVS Pharmacye0cdeccf-c32f-318a-e053-2a95a90ac4012026-01-16WarningsExact 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