FDA.reportPublic FDA data

Duravent PE

Product NDC
28595-905
11-digit product format
285950905
Labeler code
28595
Product ID
28595-905_a8aa7148-a219-4c68-895c-b3753d730526
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Allegis Pharmaceuticals, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-02-27
Marketing end
0000-00-00
Substance
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
395 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct28595-905DDiscontinued by firm2026-07-31
excluded packagepackage28595-90528595-905-60DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxymethazoline HCLOXYMETHAZOLINE HCLPreferred Pharmaceuticals Inc.cebf4a9c-b5c6-4ad8-ab7e-9bd3a80678c42026-07-29WarningsExact identifier
Pi Yuan ChinNAPHAZOLINE HYDROCHLORIDEInternational Nature Nutraceuticalse7aedab9-da4c-4494-a896-1e6ed2a956fe2025-12-27WarningsExact identifier
Childrens Multi-symptom Cold DaytimeDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.1768677d-96ec-f9f7-e063-6394a90a4ef42025-11-21WarningsExact identifier
robafen dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINPreferred Pharmaceuticals Inc.5b2fd5ce-56ab-491a-81b9-44e35a5d23162025-09-17WarningsExact identifier
TussinGUAIFENESINStrategic Sourcing Services188f3c82-b4bc-42a5-8068-c2fa0c2ac3442025-01-08WarningsExact identifier
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLStrategic Sourcing Servicese416982f-6cbb-4f48-a215-16bea8393dad2025-01-07WarningsExact identifier
QCH Adult Tussin DM 542DEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association Inc.17caffa4-a264-7f3e-e063-6394a90ac4192024-05-08WarningsExact identifier
QCH Adult Tussin DM Sugar free 545DEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association Inc.17cb91f0-32ec-9e0f-e063-6394a90a05092024-05-08WarningsExact identifier
QCH Adult Tussin 541GUAIFENESINChain Drug Marketing Association Inc.b487f4af-ad0c-4f18-9a6b-7fd386b3f46c2024-05-02WarningsExact identifier
QCH Maximum Strength Mucus Relief DM 628DEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association Inc.a2795bf5-34c6-4de6-b9e5-53a23d18e3572024-04-26WarningsExact identifier
Childrens Mucus and Cough ReliefDEXTROMETHORPHAN HBR, GUAIFENESINFamily Dollar Services, Inc.07ad76cc-2a6c-4a88-a5e9-5e8f6d1319e32024-04-17WarningsExact identifier
Quality Choice Dye Free Cherry Childrens Allergy ReliefDIPHENHYDRAMINE HCLChain Drug Marketing Association Inc.302ca7b5-f65c-4187-bbd6-f482be6e63c12024-03-18WarningsExact identifier
MUCUS RELIEF DMDEXTROMETHORPHAN HBR/GUAIFENESINKROGER COMPANY813baf42-edb0-33a9-e053-2a91aa0a85992019-05-21WarningsExact identifier
MUCUS RELIEFGUAIFENESINKROGER COMPANY813b1db2-a177-77c6-e053-2a91aa0ac73b2019-05-15WarningsExact identifier
Discount Drug Mart Value Vapor SteamCAMPHOR (SYNTHETIC)Drug Mart87230c40-ea77-0f3a-e053-2991aa0ae7842019-04-22WarningsExact identifier
Best Choice Vapor SteamCAMPHOR (SYNTHETIC)Valu merchandiser86bb3a80-c675-d478-e053-2a91aa0a8c272019-04-17WarningsExact identifier
Assured Vaporizing Chest RubCAMPHOR AND EUCALYPTUS OIL AND MENTHOLGreenbrier International, Inc.c7cdbf2f-4841-4a7a-9056-6a741abc31332019-01-19WarningsExact identifier
Assured Vaporizing Chest RubCAMPHOR AND EUCALYPTUS OIL AND MENTHOLGreenbrier International, Inc.b8f0c61e-83b0-4835-b950-2c5dcce5cf172019-01-19WarningsExact identifier
Pressure Pain Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association1e54ecb3-c3c3-477a-8725-23f24e77a44b2018-12-31WarningsExact identifier
Allergy TimeCHLORPHENIRAMINE MALEATETime Cap Labs Inc588c424a-8dd6-417e-8f76-2ce0cc2b0c122018-12-17WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland When using this prduct do not use more than directed do not use more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. temporary discomfort such as burning, stinging, sneexing, or an increased nasal discharge may occur use of this container by more than one person may spread infection

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-905-60EA - Each28595-905700693d8-7089-496a-b3f5-664b8456a49b12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQDURAVENT PE (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [ALLEGIS PHARMACEUTICALS, LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDURAVENT PE (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [ALLEGIS PHARMACEUTICALS, LLC]1
GUAIFENESINACTIVE MOIETY495W7451VQDURAVENT PE (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [ALLEGIS PHARMACEUTICALS, LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDURAVENT PE (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [ALLEGIS PHARMACEUTICALS, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDURAVENT PE (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [ALLEGIS PHARMACEUTICALS, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DURAVENT PE (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [ALLEGIS PHARMACEUTICALS, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDURAVENT PE (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [ALLEGIS PHARMACEUTICALS, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODURAVENT PE (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [ALLEGIS PHARMACEUTICALS, LLC]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DDURAVENT PE (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [ALLEGIS PHARMACEUTICALS, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EDURAVENT PE (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [ALLEGIS PHARMACEUTICALS, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DURAVENT PE (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [ALLEGIS PHARMACEUTICALS, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDURAVENT PE (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [ALLEGIS PHARMACEUTICALS, LLC]1