FDA.reportPublic FDA data

Dynarex Hydrogel

Product NDC
67777-233
Requested package NDC
67777-233-02
11-digit product format
677770233
Labeler code
67777
Product ID
67777-233_ee9dca78-070e-46bc-e053-2a95a90aa56a
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin
Dosage form
GEL
Route
TOPICAL
Labeler
Dynarex Corporation
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-05-26
Marketing end
0000-00-00
Substance
GLYCERIN
Active strength
20 g/100g
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67777-23367777-233-02DDiscontinued by firm2026-10-05

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 · 1 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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67777-23367777-233-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-233-01GM - Gram67777-233e8eb47ae-2d82-496d-9b60-f9d09e6d5d1412022-06-06
67777-233-02GM - Gram67777-23397212696-490a-4323-96ff-1099a4dfebcc12023-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXDYNAREX HYDROGEL (GLYCERIN) GEL [DYNAREX CORPORATION]12
GLYCERINACTIVE MOIETYPDC6A3C0OXDYNAREX HYDROGEL (GLYCERIN) GEL [DYNAREX CORPORATION]12
ALLANTOININACTIVE INGREDIENT344S277G0ZDYNAREX HYDROGEL (GLYCERIN) GEL [DYNAREX CORPORATION]12
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XDYNAREX HYDROGEL (GLYCERIN) GEL [DYNAREX CORPORATION]12
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0DYNAREX HYDROGEL (GLYCERIN) GEL [DYNAREX CORPORATION]12
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4DYNAREX HYDROGEL (GLYCERIN) GEL [DYNAREX CORPORATION]12
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUDYNAREX HYDROGEL (GLYCERIN) GEL [DYNAREX CORPORATION]12
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDYNAREX HYDROGEL (GLYCERIN) GEL [DYNAREX CORPORATION]12
POLYOXYL 60 HYDROGENATED CASTOR OILINACTIVE INGREDIENT02NG325BQGDYNAREX HYDROGEL (GLYCERIN) GEL [DYNAREX CORPORATION]12
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DYNAREX HYDROGEL (GLYCERIN) GEL [DYNAREX CORPORATION]12
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDYNAREX HYDROGEL (GLYCERIN) GEL [DYNAREX CORPORATION]12
WATERINACTIVE INGREDIENT059QF0KO0RDYNAREX HYDROGEL (GLYCERIN) GEL [DYNAREX CORPORATION]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-233DYNAREX HYDROGEL (GLYCERIN) GEL [DYNAREX CORPORATION]19Legacy NDC20241122_c92de291-2cab-429d-9ae1-a1e85d5d784e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-233-026777702330224 TUBE in 1 CASE (67777-233-02) > 84.7 g in 1 TUBE (67777-233-01) 24 tube2010-05-260000-00-00NoNoCurrent