FDA.reportPublic FDA data

Glycerin

Product NDC
68016-015
11-digit product format
680160015
Labeler code
68016
Product ID
68016-015_4147d0b9-1055-875a-e063-6294a90a63bb
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Chain Drug Consortium LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-03-15
Substance
GLYCERIN
Active strength
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
2026-12-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN2 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
104155Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4694f05b-d927-4e15-9630-a0a1cddb3cbbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-015-79Glycerin25 in 1 JARSUPPOSITORY2512
68016-015-80Glycerin50 in 1 JARSUPPOSITORY5012
68016-015-81Glycerin100 in 1 JARSUPPOSITORY10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-015-79EA - Each68016-01532781bb2-c0bf-470c-ba1d-88bb3972e10512022-06-06
68016-015-80EA - Each68016-015d3bf11b7-d20b-4134-88eb-0c8c43d879cc12022-06-06
68016-015-81EA - Each68016-0153a444d56-2c92-440b-a5c4-9c951ec5900812022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-015GLYCERIN (GLYCERIN) SUPPOSITORY [CHAIN DRUG CONSORTIUM LLC]11Current NDC, Legacy NDC, 3 package rows20241215_4694f05b-d927-4e15-9630-a0a1cddb3cbb.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 27 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BisacodylBISACODYL SUPPOSITORIESOncor Pharmaceuticals6f0aefc9-cd5f-4bdd-89c2-b6a80558987c2025-01-24WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMNuCare Pharmaceuticals, Inc.2c65319f-6cf5-aa90-e063-6394a90ad6622025-01-23WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATECardinal Health (Leader) 70000cde87f95-73c0-46f5-9349-37e04096048c2025-01-22WarningsExact identifier
application number: M007
Senna-TabsSENNA 8.6MGUlai Health LLC485129a0-8340-4f61-be51-5abff5032b8d2025-01-20WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILTopco Associates, LLC0609468d-ee66-49af-be40-e51965b88f6f2025-01-20WarningsExact identifier
application number: M007
Soluble FiberMETHYLCELLULOSEUnited Natural Foods, Inc. dba UNFI6decd5ef-e8e1-44ae-8465-6266cf18e81e2025-01-20WarningsExact identifier
application number: M007
PerdiemSENNOSIDES, STIMULANT LAXATIVEHaleon US Holdings LLC6b256c8f-3953-4c69-9a16-ffa0511bdbcd2025-01-16WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDESEverpharm LLC0ea9f2b5-4533-4b71-b019-10ecb3c064592025-01-16WarningsExact identifier
application number: M007
Anecream 5LIDOCAINE 5%Focus Health Group1810edc3-093e-402f-bcb0-9c731da283a72025-01-15WarningsExact identifier
application number: M007
SennaSENNOSIDESReliable 1 Laboratories LLCae46a611-20f2-74c8-e053-2995a90a32ce2025-01-15WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES, DOCUSATE SODIUMReliable-1 Laboratories LLCa97a1829-f62f-2014-e053-2a95a90a8cc52025-01-15WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs4d678da0-9ada-4d00-9db9-33b45c7761072025-01-15WarningsExact identifier
application number: M007
Goodsense Fiber laxative 147CALCIUM POLYCARBOPHILGoodSense17f5570b-be85-9dce-e063-6294a90abeaf2025-01-14WarningsExact identifier
application number: M007
Sunmark Mineral Oil LaxativeMINERAL OILStrategic Sourcing Servicesc54f7df2-3845-425f-b13e-3dc000123f3c2025-01-14WarningsExact identifier
application number: M007
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGUlai Health LLCc0e27b02-8ef2-4239-8f8c-790f7d978dc02025-01-12WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMMajor Pharmaceuticals1541ff5b-11f8-444b-a2a0-8e3086ae650a2025-01-10WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAvPAKf31a4349-7826-45c0-9388-6b938d167b7a2025-01-09WarningsExact identifier
application number: M007
Docusate sodiumDOCUSATE SODIUMAPNAR PHARMA LP05b0732b-012f-78ee-e063-6294a90a839a2025-01-09WarningsExact identifier
application number: M007
Foster and Thrive Ready to Use Saline LaxativeSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMMcKessone5fdfcfd-5340-4929-9f68-2696110cca8e2025-01-07WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILSHANDONG XINHUA PHARMACEUTICAL CO., LTD.ee06868b-f741-8da2-e053-2a95a90a97722025-01-02WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104155glycerin 2 GM Rectal SuppositoryPSN4694f05b-d927-4e15-9630-a0a1cddb3cbb12
104155glycerin 2000 MG Rectal SuppositorySCD4694f05b-d927-4e15-9630-a0a1cddb3cbb12
104155glycerin 2 GM Rectal SuppositorySY4694f05b-d927-4e15-9630-a0a1cddb3cbb12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-015-796801600157925 SUPPOSITORY in 1 JAR (68016-015-79) 25 suppository2012-03-150000-00-00NoNoCurrent
68016-015-806801600158050 SUPPOSITORY in 1 JAR (68016-015-80) 50 suppository2012-03-150000-00-00NoNoCurrent
68016-015-8168016001581100 SUPPOSITORY in 1 JAR (68016-015-81) 100 suppository2012-03-150000-00-00NoNoCurrent