FDA.reportPublic FDA data

Glycerin Laxative

Product NDC
13709-322
11-digit product format
137090322
Labeler code
13709
Product ID
13709-322_2beb2049-b67f-b7a5-e063-6394a90a3a15
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin based Gentle and Effective Laxative Adult Constipation Relief
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
NeilMed Pharmaceuticals Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-24
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct13709-322UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13709-32213709-322-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…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 Laxative
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
03b4be69-6488-76be-e063-6394a90a7edfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-322-01Glycerin Laxative25 in 1 JARSUPPOSITORY252
13709-322-01Glycerin Laxative1 in 1 CAPSULESUPPOSITORY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-322GLYCERIN LAXATIVE (GLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEF) SUPPOSITORY [NEILMED PHARMACEUTICALS INC.]2Current NDC, 2 package rows20250119_03b4be69-6488-76be-e063-6394a90a7edf.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 18 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hemorrhoid Pain ReliefLIDOCAINETelebrands Corp04164425-ca3b-ef24-e063-6294a90a59d82024-11-20WarningsExact identifier
application number: M015
Hempvana Maximum Strength Pain Relief Topical AnestheticLIDOCAINETelebrands Corpf525075a-d7ee-dad0-e053-2a95a90a6f3f2024-11-20WarningsExact identifier
application number: M015
Curist Lidocaine Numbing ReliefLIDOCAINELittle Pharma, Inc.bff3c422-a0df-6196-e053-2a95a90af0332024-11-20WarningsExact identifier
application number: M015
Hempvana Maximum Strength Pain Relief Topical Anesthetic PlatinumLIDOCAINE 5%Telebrands Corp2774ec41-7366-ac8c-e063-6394a90a1ee22024-11-20WarningsExact identifier
application number: M015
Walgreens Anorectal Lidocaine Cream5% LIDOCAINEWalgreens Company3052fac7-fd68-43f4-9950-8c07288a6b6d2024-11-20WarningsExact identifier
application number: M015
Lidocaine AnorectalLIDOCAINEPatrin Pharma, Inc456d41fe-8449-4980-9291-d7a3b65a900d2024-11-13WarningsExact identifier
application number: M015
MyDermPENYLEPHRINE HCI, WITCH HAZEL, LIDOCAINE HCL,Inspec Solution LLC.2618eba1-9308-a666-e063-6394a90ac3d22024-11-04WarningsExact identifier
application number: M015
Granulotion MedicatedMENTHOL, ZINC OXIDEGL HEALTH, INC.01701780-b160-415b-b34d-3622371794752024-10-29WarningsExact identifier
application number: M015
rexall hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLDolgencorp Inc0415c51b-5a12-49d4-8968-0131ddb855452024-10-23WarningsExact identifier
application number: M015
Exchange Select HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLArmy & Air Force Exchange Service8155ed74-9412-498f-998c-4a29c46e934f2024-10-23WarningsExact identifier
application number: M015
Leader HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leaderc4814524-0f4c-4351-a431-5b4b6431fd282024-10-23WarningsExact identifier
application number: M015
basic care hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLAmazon.com Services LLC617d9213-31f0-4c71-be0c-7961b96e51432024-10-23WarningsExact identifier
application number: M015
Signature Care HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLSafewaye74b71a1-915d-4e5b-b548-d5cce7945dbd2024-10-23WarningsExact identifier
application number: M015
Equaline HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFId29b7824-ff9e-4875-b3de-92721c8add0e2024-10-23WarningsExact identifier
application number: M015
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLPublix Super Markets Inca241cb37-7007-4fd8-a12e-f3fc6d6f780e2024-10-22WarningsExact identifier
application number: M015
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLKroger Companyd44ca22a-dc20-454d-99aa-403a8c7a3e002024-10-22WarningsExact identifier
application number: M015
rugby hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLRugby Laboratoriesc1a126b5-0d34-437f-a7ef-8d5cbeb7b03b2024-10-22WarningsExact identifier
application number: M015
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLMeijer Distribution Inc1431397e-3515-4794-a494-70667948e14c2024-10-18WarningsExact identifier
application number: M015
signature care hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLSafewayafcf68cf-f187-44d3-ad91-b1e79b182bc62024-10-17WarningsExact identifier
application number: M015
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLH E B1435432d-5ff2-468b-808d-fb0c99a0717b2024-10-17WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104155glycerin 2 GM Rectal SuppositoryPSN03b4be69-6488-76be-e063-6394a90a7edf2
104155glycerin 2000 MG Rectal SuppositorySCD03b4be69-6488-76be-e063-6394a90a7edf2
104155glycerin 2 GM Rectal SuppositorySY03b4be69-6488-76be-e063-6394a90a7edf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13709-322-011370903220125 CAPSULE in 1 JAR (13709-322-01) / 1 SUPPOSITORY in 1 CAPSULE25 capsule2023-08-24NoNoCurrent