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 4 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEMORRHOIDALMINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INC93482a9b-145b-42d4-96db-599c281a39f12026-06-10WarningsExact identifier
application number: M015
Oudetas Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.53f11395-f460-943f-e063-6294a90affef2026-06-10WarningsExact identifier
application number: M015
Terramed Just Think Comfort Hemorrhoidal WipesLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDERida LLCf6ad00e7-c7b8-40b8-80c2-6e6bf85098b32026-06-08WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELCVS Pharmacy, Inc.50f920da-b41a-480d-b3a0-df940caaee2d2026-06-08Warnings, Adverse reactionsExact identifier
application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd5356cf53-935d-a02f-e063-6394a90a6e5a2026-06-05WarningsExact identifier
application number: M015
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
application number: M015
Healcome Lidocaine Numbing CreamLIDOCAINEYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD9b4eac02-1b1f-4630-92b4-b1d8c21abab52026-05-29WarningsExact identifier
application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Lavender and chamomileTOLNAFTATERida LLC5517c43f-03b2-499a-a217-d9cba3fb9fd22026-05-27WarningsExact identifier
application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash CitrusTOLNAFTATERida LLCb4c5da66-5928-4352-ab90-fd46039e79552026-05-27WarningsExact identifier
application number: M015
Terramed Just Think Comfort GynoCare BV Guard Intimate WipesPRAMOXINE HYDROCHLORIDERida LLCbb29f156-37b8-400e-802b-3e2671cb7dc82026-05-27WarningsExact identifier
application number: M015
myDerm MEDICAL NEW Soothing HemorrhoidalWITCH HAZEL PENYLEPHRINE LIDOCAINEInspec Solutions2ff42501-7730-42de-99dd-6fc53bbdf25f2026-05-27WarningsExact identifier
application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Icy Cool MentholTOLNAFTATERida LLC8b15cb3b-f7cb-4a80-94b2-eeeafc9794e82026-05-27WarningsExact identifier
application number: M015
Lidocaine Roll-onLIDOCAINEYYBA Corp52d060df-2095-dd68-e063-6394a90a77402026-05-27WarningsExact identifier
application number: M015
PUVIDA NUMBING Cream Anorectal (Hemorrhoidal) CreamLIDOCAINE 5% NUMBING CREAM ANORECTAL (HEMORRHOIDAL) CREAMJiangxi Yudexi Pharmaceutical Co., LTD52a25b97-7721-6410-e063-6394a90a228f2026-05-25WarningsExact identifier
application number: M015
Arlun LIDOCAINE CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5241c26b-6c91-65a5-e063-6394a90a24772026-05-20WarningsExact identifier
application number: M015
tuiwaro LIDOCAINE CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5223b7fe-6aba-c77b-e063-6394a90ad27b2026-05-18WarningsExact identifier
application number: M015
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
application number: M015
OxifyLIDOCAINE 5%Weeks & Leo Compnay, INC.51cd58f7-c1c9-f4e2-e063-6294a90ad9702026-05-14WarningsExact identifier
application number: M015
Lidocaine anorectal creamLIDOCAINE 5%EveryMarket Inc1604daec-812f-4684-ba98-fbcda07a74612026-05-12WarningsExact identifier
application number: M015
PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPESWITCH HAZELHaleon US Holdings LLC485437a8-b2e9-4acf-a20e-edb1f08a9cae2026-05-11WarningsExact 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