MedPath

nasal decongestant

Meijer Distribution, Inc. Nasal Decongestant Drug Facts

Approved
Approval ID

4d431663-4b6a-4b00-9bbd-87d2c6b8ddad

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 4, 2025

Manufacturers
FDA

Meijer Distribution Inc

DUNS: 006959555

Products 1

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

pseudoephedrine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code41250-809
Application NumberANDA075153
Product Classification
M
Marketing Category
C73584
G
Generic Name
pseudoephedrine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 4, 2025
FDA Product Classification

INGREDIENTS (10)

PSEUDOEPHEDRINE HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: 6V9V2RYJ8N
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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