FDA.reportPublic FDA data

Glycerin

Product NDC
46122-221
11-digit product format
461220221
Labeler code
46122
Product ID
46122-221_4147d1ac-9ee0-6442-e063-6294a90a576f
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Amerisource Bergen/Good Neighbor Pharmacy
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-09-12
Substance
GLYCERIN
Active strength
2.1 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage46122-221-63IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage46122-221-71IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage46122-221-63IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage46122-221-71IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage46122-221-63IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage46122-221-71IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage46122-221-63IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage46122-221-71IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage46122-221-71UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage46122-221-63UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage46122-221-71UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage46122-221-63UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage46122-221-71UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage46122-221-63UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
GLYCERIN2.1 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
583084Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e6a8914f-cfd9-4c72-abaa-22189bf0faefAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
46122-221-632025-07-02GNP Glycerin Supp.
46122-221-632025-07-02GNP Glycerin Supp.
46122-221-712025-07-02GNP Glycerin Supp.
46122-221-712025-07-02GNP Glycerin Supp.
46122-221-632025-01-30GNP Glycerin Supp.
46122-221-632025-01-30GNP Glycerin Supp.
46122-221-712025-01-30GNP Glycerin Supp.
46122-221-712025-01-30GNP Glycerin Supp.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-221-63Glycerin25 in 1 JARSUPPOSITORY2511
46122-221-71Glycerin50 in 1 JARSUPPOSITORY5011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-221-63EA - Each46122-221ef78bcd7-30bc-4df8-b7e5-bd3e8eb0978c12013-10-17
46122-221-71EA - Each46122-22112ac563a-74be-4ff3-8d4d-a32a1c80333512013-10-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-221GLYCERIN (GLYCERIN) SUPPOSITORY [AMERISOURCE BERGEN/GOOD NEIGHBOR PHARMACY]8Current NDC, Legacy NDC, 2 package rows20231209_e6a8914f-cfd9-4c72-abaa-22189bf0faef.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 6 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature CareCASTORBetter Living Brands, LLC4947cf4d-3ebd-4b66-9582-f141407aa3002026-06-15Warnings, Adverse reactionsExact identifier
application number: M007
WALGREEN GLYCERIN ADULTGLYCERIN SUPPOSITORYWalgreens20c44346-0b29-7364-e063-6294a90a648f2026-06-15WarningsExact identifier
application number: M007
WALGREENS GLYCERINGLYCERIN SUSPENSIONWalgreens20c44346-0b2b-7364-e063-6294a90a648f2026-06-15WarningsExact identifier
application number: M007
Stratuscare BisacodylBISACODYLStratus Pharmaceuticals795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2d2026-06-09WarningsExact identifier
application number: M007
LaxativeLAXATIVEAllegiant Health596b11de-cf17-4c55-8638-49f387e5fac42026-06-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)16691fd4-cdf3-41d4-b851-5fa148a054682026-06-08WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDECardinal Health 107, LLC144c7242-4ff9-404a-86bf-48e2871eb0cd2026-06-05WarningsExact identifier
application number: M007
Senna Natural VegetableSENNOSIDESMedline Industries, LP9a6240f3-398c-06b8-e053-2995a90a73df2026-06-04WarningsExact identifier
application number: M007
Senna SSENNOSIDES AND DOCUSATE SODIUMMedline Industries, LP6cd22881-db60-9045-e053-2991aa0ae08a2026-06-04WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMNuCare Pharmaceuticals, Inc.53727f3a-914c-0e2c-e063-6394a90a38862026-06-04WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEGeri-Care Pharmaceuticals, Corp99eb67ca-301c-dfdb-e053-2a95a90aff6f2026-05-28WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATECVS PHARMACY, INC1f9e72dc-a394-420d-8fe8-fc4d0f6906ed2026-05-27WarningsExact identifier
application number: M007
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens5285403b-ab44-21a1-e063-6394a90a9fd02026-05-23WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy9983095a-6ef4-4ad7-acc5-e34221fb7c632026-05-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS PHARMACY, INC056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a1382026-05-20WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDES 8.8MG/5MLAldama Pharmaceuticals, Inc491255c6-465f-a78a-e063-6394a90aa4082026-05-15WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES AND DOCUSATE SODIUMCardinal Health 107, LLC40385b89-a855-4ca2-992a-df5eb677be152026-05-15WarningsExact identifier
application number: M007
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMMajor Pharmaceuticalscc8d1556-f108-4166-837c-48f81152877e2026-05-12WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEGOODSENSEa9509715-cc4f-595d-e053-2a95a90ae31f2026-05-11WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCee14dfe2-405f-493a-a774-ce1b01d05dd42026-05-05WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
583084glycerin 2.1 GM Adult Rectal SuppositoryPSNe6a8914f-cfd9-4c72-abaa-22189bf0faef11
583084glycerin 2100 MG Rectal SuppositorySCDe6a8914f-cfd9-4c72-abaa-22189bf0faef11
583084glycerin 2.1 GM Rectal SuppositorySYe6a8914f-cfd9-4c72-abaa-22189bf0faef11
583084glycerin 82.5 % Adult Rectal SuppositorySYe6a8914f-cfd9-4c72-abaa-22189bf0faef11
583084glycerin 2.1 GM Adult Rectal SuppositoryPSN89b5d376-f8c6-4c86-9dd8-67d047d0d45b1
583084glycerin 2100 MG Rectal SuppositorySCD89b5d376-f8c6-4c86-9dd8-67d047d0d45b1
583084glycerin 2.1 GM Rectal SuppositorySY89b5d376-f8c6-4c86-9dd8-67d047d0d45b1
583084glycerin 82.5 % Adult Rectal SuppositorySY89b5d376-f8c6-4c86-9dd8-67d047d0d45b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-221-634612202216325 SUPPOSITORY in 1 JAR (46122-221-63) 25 suppository2013-09-120000-00-00NoNoCurrent
46122-221-714612202217150 SUPPOSITORY in 1 JAR (46122-221-71) 50 suppository2013-09-120000-00-00NoNoCurrent