FDA.reportPublic FDA data

Monistat Maintain

Product NDC
63736-020
11-digit product format
637360020
Labeler code
63736
Product ID
63736-020_e114e8a0-7f90-4363-8d44-eacb4bce5df7
Type
HUMAN OTC DRUG
Nonproprietary name
Phenazopyridine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Insight Pharmaceuticals LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-03-01
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
99.5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Monistat Maintain
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE99.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0EWG668W17Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094147Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d1e563fc-5a91-4867-8177-93102bd24fe4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-020-12Monistat Maintain1 in 1 CARTONTABLET12
63736-020-12Monistat Maintain12 in 1 BLISTER PACKTABLET122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-020MONISTAT MAINTAIN (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [INSIGHT PHARMACEUTICALS LLC]1Current NDC, 2 package rows20250302_d1e563fc-5a91-4867-8177-93102bd24fe4.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Monistat MaintainPHENAZOPYRIDINE HYDROCHLORIDEInsight Pharmaceuticals LLCd1e563fc-5a91-4867-8177-93102bd24fe42025-10-23WarningsExact identifier
ndc (product): 63736-020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSNd1e563fc-5a91-4867-8177-93102bd24fe42
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCDd1e563fc-5a91-4867-8177-93102bd24fe42
1094147phenazopyridine HCl 99.5 MG Oral TabletSYd1e563fc-5a91-4867-8177-93102bd24fe42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63736-020-12637360020121 BLISTER PACK in 1 CARTON (63736-020-12) / 12 TABLET in 1 BLISTER PACK1 blister pack2025-03-01NoNoCurrent