Home NDC 62135-404 PHENAZOPYRIDINE HYDROCHLORIDE
Product NDC 62135-404
11-digit product format 621350404
Labeler code 62135
Product ID 62135-404_45ae56cd-d6c6-3ad2-e063-6394a90a8ebf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PHENAZOPYRIDINE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-08-23
Substance PHENAZOPYRIDINE HYDROCHLORIDE
Active strength 200 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions ADVERSE REACTIONS Headache, rash, pruritus and occasional gastrointestinal disturbance. An anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see OVERDOSAGE Section ).
Additional Listing Data#
Finished product Yes
Brand name base PHENAZOPYRIDINE HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 0EWG668W17 Rxcui 1094104, 1094107
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-404-60 PHENAZOPYRIDINE HYDROCHLORIDE 60 in 1 BOTTLE TABLET 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-404 PHENAZOPYRIDINE HYDROCHLORIDE TABLET [CHARTWELL RX, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20241025_9ed3cf8c-e1c1-4290-b094-25ac6f7a9a56.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62135-404-60 62135040460 60 TABLET in 1 BOTTLE (62135-404-60) 60 tablet 2022-09-01 0000-00-00 No No Current