FDA.reportPublic FDA data

Pharbinex-PE

Product NDC
73057-389
11-digit product format
730570389
Labeler code
73057
Product ID
73057-389_2c2a2804-8a2b-be5d-e063-6394a90a9763
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN 400mg and PHENYLEPHRINE HCL 10MG
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Ulai Health LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-18
Substance
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
400; 10 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
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 packagepackage73057-389-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73057-389-040efc9e666f02…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-PE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 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
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1304111Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e459bb83-b1d6-42fc-aa46-99ad117e6144Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73057-389-042022-01-31C16284748780-1d6a99b39-9ec4-a426-e053-dadaa90af4c2Drug Facts
73057-389-042022-01-28C16284748780-1d6a99b39-9ec4-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73057-389-04Pharbinex-PE30 in 1 BOTTLE, PLASTICTABLET, COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73057-389PHARBINEX-PE (GUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MG) TABLET, COATED [ULAI HEALTH LLC]3Current NDC, Legacy NDC, 1 package rows20250122_e459bb83-b1d6-42fc-aa46-99ad117e6144.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 174 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCOSAGUAIFENESINTIME CAP LABORATORIES,INCd34ef2e8-adc2-48e5-a572-e354937daec62023-11-02WarningsExact identifier
application number: M012
Daytime Severe and Nighttime Severe cold and fluDAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION09286d15-b63f-a9de-e063-6294a90ab9482023-11-02WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6cece6c-23e4-7811-e053-6394a90a106a2023-11-02WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.eb64750f-19ac-655f-e053-2995a90a33b52023-11-02WarningsExact identifier
application number: M012
Multi-Symptom Mapap Cold FormulaACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLProficient Rx LP9bf81b26-38b4-486c-ae89-222119ce1a4f2023-11-01WarningsExact identifier
application number: M012
Guaifenesin Syrup and DextromethorphanGUAIFENESIN SYRUP AND DEXTROMETHORPHANNatco Pharma USA LLCad9026f4-f0b6-4d02-aa44-f0460eeefc0e2023-11-01WarningsExact identifier
application number: M012
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HYDROCHLORIDENatco Pharma USA LLC54b64354-ac10-42ff-a53d-96cef933a91a2023-11-01WarningsExact identifier
application number: M012
children allergy relief dye free cherryDIPHENHYDRAMINE HCLA-S Medication Solutions5c6c1809-4c6f-4e8f-a5ae-9796e821d4002023-11-01WarningsExact identifier
application number: M012
Daytime and Nighttime Cherry Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION0903b222-1a44-64aa-e063-6294a90abba02023-10-31WarningsExact identifier
application number: M012
Ephrine Nose DropsPHENYLEPHRINE HYDROCHLORIDEWalgreensb620eb9f-2caf-0942-e053-2a95a90ae48e2023-10-31WarningsExact identifier
application number: M012
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLA-S Medication Solutions204849d1-ac4b-4dbe-8769-fcb30291f8802023-10-31WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefDAYTIME COLD AND FLU RELIEFTopCo Associates, LLCd592fbb8-d4bf-444e-982e-edf6fe97dce42023-10-31WarningsExact identifier
application number: M012
Nite Time Cold and Flu ReliefNITE TIME COLD AND FLU RELIEFTopCo Associates, LLC407dc4ae-882d-4a49-8884-ef048bb404cf2023-10-31WarningsExact identifier
application number: M012
12 Hour Original Nasal DecongestantNASAL SPRAYSheffield Pharmaceuticals LLCcea0ce76-ae75-4484-a7c2-ff1086e9d8b02023-10-30WarningsExact identifier
application number: M012
Mucosa DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMagno-Humphries, Inc.3a5533fb-1c83-4b95-9cd2-9be663d3ff5f2023-10-27WarningsExact identifier
application number: M012
Mucosa GuifenesinGUAIFENESINMagno-Humphries, Inc.9d22c208-d0ae-8b6a-e053-2995a90ab90a2023-10-27WarningsExact identifier
application number: M012
DG Health Cough Drops Cherry FlavorMENTHOLDollar General Corporationc7a603d8-72fb-9626-e053-2995a90a09ea2023-10-26WarningsExact identifier
application number: M012
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEGeri-Care Pharmaceutical Corp92d90b41-0627-121e-e053-2995a90a2df12023-10-26WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol CherryMENTHOLRiclan S.A.8e471265-3594-451a-8921-f0db474abe852023-10-26WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol EucalyptusMENTHOLRiclan S.A.1141593a-f3ba-4adf-b332-f9fcb0b5a0132023-10-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1304111guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral TabletPSNe459bb83-b1d6-42fc-aa46-99ad117e61443
1304111guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral TabletSCDe459bb83-b1d6-42fc-aa46-99ad117e61443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73057-389-047305703890430 TABLET, COATED in 1 BOTTLE, PLASTIC (73057-389-04) 2019-07-180000-00-00NoNoCurrent