FDA.reportPublic FDA data

Proctozone-G

Product NDC
57237-338
11-digit product format
572370338
Labeler code
57237
Product ID
57237-338_553c8839-ee7f-4b94-986f-69ddfbf085c5
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Rising Pharma Holdings, Inc.
Application
M007.54
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-31
Substance
GLYCERIN
Active strength
1.2 g/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Proctozone-G
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN1.2 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
421299Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8a5c8ad5-3619-4971-967d-165270a20bc8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-338-16Proctozone-G6 in 1 BLISTER PACKSUPPOSITORY62
57237-338-21Proctozone-G2 in 1 CARTONSUPPOSITORY22
57237-338-51Proctozone-G5 in 1 BLISTER PACKSUPPOSITORY52
57237-338-52Proctozone-G5 in 1 CARTONSUPPOSITORY52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-338-21EA - Each57237-338d9975424-28d8-4056-bba0-12a65ba68c4912026-03-17
57237-338-52EA - Each57237-33852363b9a-647e-4086-b413-4bb3dada1f9712026-03-17

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
Proctozone-GGLYCERINRising Pharma Holdings, Inc.8a5c8ad5-3619-4971-967d-165270a20bc82026-01-06WarningsExact identifier
ndc (product): 57237-338

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
421299glycerin 1.2 GM Pediatric Rectal SuppositoryPSN8a5c8ad5-3619-4971-967d-165270a20bc82
421299glycerin 1200 MG Rectal SuppositorySCD8a5c8ad5-3619-4971-967d-165270a20bc82
421299glycerin 1.2 GM Rectal SuppositorySY8a5c8ad5-3619-4971-967d-165270a20bc82
421299glycerin 82.5 % Pediatric Rectal SuppositorySY8a5c8ad5-3619-4971-967d-165270a20bc82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57237-338-16572370338166 in 1 BLISTER PACKHistorical
57237-338-21572370338212 BLISTER PACK in 1 CARTON (57237-338-21) / 6 SUPPOSITORY in 1 BLISTER PACK (57237-338-16) 2 blister pack2025-07-31NoNoCurrent
57237-338-51572370338515 in 1 BLISTER PACKHistorical
57237-338-52572370338525 BLISTER PACK in 1 CARTON (57237-338-52) / 5 SUPPOSITORY in 1 BLISTER PACK (57237-338-51) 5 blister pack2025-07-31NoNoCurrent