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DERMFREE ORIGINAL NASAL

Approved
Approval ID

3432c4a6-3e48-db91-e063-6394a90a28ee

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 2, 2025

Manufacturers
FDA

Jiangxi Yudexi Pharmaceutical Co., LTD

DUNS: 455662836

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Naphazoline HCL 0.05% ORIGINAL NASAL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85248-006
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Naphazoline HCL 0.05% ORIGINAL NASAL
Product Specifications
Route of AdministrationNASAL
Effective DateMay 2, 2025
FDA Product Classification

INGREDIENTS (5)

BORNEOLInactive
Code: M89NIB437X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
NAPHAZOLINE HCLActive
Quantity: 0.05 g in 100 mL
Code: MZ1131787D
Classification: ACTIB
CAMPHOR (SYNTHETIC)Inactive
Code: 5TJD82A1ET
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

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DERMFREE ORIGINAL NASAL - FDA Drug Approval Details