Glycerin

Product NDC: 63868-282
Requested package NDC: 63868-282-25
11-digit product format: 638680282
Labeler code: 63868
Product ID: 63868-282_efb9f831-0236-505a-e053-2a95a90a285f
Type: HUMAN OTC DRUG
Nonproprietary name: Glycerin
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Chain Drug Marketing Association Inc.
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-03-20
Marketing end: 0000-00-00
Substance: GLYCERIN
Active strength: 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63868-282	63868-282-25	I	Inactivated by FDA		2026-10-05

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-282-25	Glycerin	25 in 1 JAR	SUPPOSITORY	25		8

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-282	GLYCERIN (GLYCERIN) SUPPOSITORY [CHAIN DRUG MARKETING ASSOCIATION INC.]	8	Legacy NDC, 1 package rows	20241215_5e84a72c-868d-396b-e053-2991aa0a5787.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PDC6A3C0OX	GLYCERIN	56-81-5	GLYCERIN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
421299	glycerin 1.2 GM Pediatric Rectal Suppository	PSN	5e84a72c-868d-396b-e053-2991aa0a5787	8
421299	glycerin 1200 MG Rectal Suppository	SCD	5e84a72c-868d-396b-e053-2991aa0a5787	8
421299	glycerin 1.2 GM Rectal Suppository	SY	5e84a72c-868d-396b-e053-2991aa0a5787	8
421299	glycerin 82.5 % Pediatric Rectal Suppository	SY	5e84a72c-868d-396b-e053-2991aa0a5787	8

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-282-25	63868028225	25 SUPPOSITORY in 1 JAR (63868-282-25)	25 suppository	2012-03-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quality Choice Pediatric Glycerin Supp	Chain Drug Marketing Association Inc. \| DSC Laboratories Inc.	2024-12-12	HUMAN OTC DRUG LABEL	8