FDA.reportPublic FDA data

Glycerin

Product NDC
13709-333
11-digit product format
137090333
Labeler code
13709
Product ID
13709-333_510f52fc-dcf1-13fe-e063-6294a90aa047
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin Suppositories
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Neilmed Pharmaceuticals Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-11
Substance
GLYCERIN
Active strength
1 g/1.25g
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN1 g/1.25g

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
252062Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
374a2ca3-ee04-09a7-e063-6394a90ab760Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-333-01Glycerin10 in 1 CARTONSUPPOSITORY103
13709-333-01Glycerin1.2 g in 1 BLISTER PACKSUPPOSITORY1.23
13709-333-02Glycerin25 in 1 JARSUPPOSITORY253
13709-333-02Glycerin1.2 g in 1 BLISTER PACKSUPPOSITORY1.23

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 10 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLPranicura Products LLCaf520a58-3f3c-4d28-a41f-3ed8f74da0952025-11-04WarningsExact identifier
application number: M015
ProCure ClamaPlexZINC OXIDE 20.625, MENTHOL 0.44, WHITE PETROLATUM 66.335Twin Med LLC3d366857-5178-9032-e063-6294a90a40f32025-11-01WarningsExact identifier
application number: M015
GNP HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE, HCLAmerisource Bergenb0f0ef97-9add-717f-e053-2a95a90a0eb02025-10-30WarningsExact identifier
application number: M015
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
application number: M015
Hemorrhoid AnestheticMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUniversal Distribution Center LLC186c2d32-e8c5-d13d-e063-6294a90a2b0e2025-10-30WarningsExact identifier
application number: M015
WorkvieLIDOCAINE HCL, MENTHOLMarketites LLCaebaffb5-58dd-ebd5-e053-2a95a90a14ed2025-10-29WarningsExact identifier
application number: M015
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMPublix Super Markets Inc354a640c-bc7e-45c8-9df0-8b5b01767f5c2025-10-29WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLPharmacy Value Alliance LLC903b77fc-02bf-73b6-e053-2a95a90ad4cc2025-10-24WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLCVS Pharmacy845fc11b-707d-2027-e053-2991aa0a1c8a2025-10-24WarningsExact identifier
application number: M015
Calmol 4ZINC OXIDE AND COCOA BUTTERResical Inc.5516f800-d3fa-4b90-a3eb-c0bdf3183b9b2025-10-24WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLAmerisourcebergen Drug Corporation231a850a-bad6-9a30-e063-6394a90a0fdc2025-10-24WarningsExact identifier
application number: M015
Signature Care Hemorrhoidal Cream (with applicator)PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUMBETTER LIVING BRANDS, LLCb026a386-5e38-52ed-e053-2a95a90a6b0e2025-10-24WarningsExact identifier
application number: M015
AmericaineBENZOCAINEInsight Pharmaceuticals LLCd13c022f-2f91-40b4-bd66-0cfc0e147a5f2025-10-23WarningsExact identifier
application number: M015
Winco HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEWinco Foods, LLC04ca3ef1-fc6b-4683-b236-a75afc031fb52025-10-23WarningsExact identifier
application number: M015
Signature Care Medicated CoolingWITCH HAZELBetter Living Brands, LLCb35dc719-a5a2-4839-870d-25313d3f7c9b2025-10-22WarningsExact identifier
application number: M015
Family Care HemorrhoidalMINERAL OILUnited Exchange Corp04375257-f4f3-48c3-a338-de43298b95eb2025-10-22WarningsExact identifier
application number: M015
Family Wellness HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCLFamily Dollar Services, Incfe3293bc-80b5-b60a-e053-6394a90a4ede2025-10-22WarningsExact identifier
application number: M015
Xesso Rear Comfort GlideLIDOCAINEPREMIUM NATURAL COSMETICS INCe9eb262e-a1c1-7d5c-e053-2a95a90a7c9f2025-10-22WarningsExact identifier
application number: M015
Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.41a6d309-2722-1738-e063-6294a90a8a702025-10-21WarningsExact identifier
application number: M015
DERMOSCRIBE ICHYBUMHYDROCORTISONE, CLIOQUINOL, ZINC OXIDEDERMOSCRIBE PTY LTD134a88a1-13e5-4da0-8270-c380b57aaeb72025-10-17WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252062glycerin 1 GM pediatric Rectal SuppositoryPSN374a2ca3-ee04-09a7-e063-6394a90ab7603
252062glycerin 1000 MG Rectal SuppositorySCD374a2ca3-ee04-09a7-e063-6394a90ab7603
252062glycerin 1 GM pediatric Rectal SuppositorySY374a2ca3-ee04-09a7-e063-6394a90ab7603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13709-333-011370903330110 BLISTER PACK in 1 CARTON (13709-333-01) / 1.2 g in 1 BLISTER PACK10 blister pack2025-06-11NoNoCurrent
13709-333-021370903330225 BLISTER PACK in 1 JAR (13709-333-02) / 1.2 g in 1 BLISTER PACK25 blister pack2026-05-07NoNoCurrent