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 Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX
Rxcui421299

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

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