FDA.reportPublic FDA data

Avedana HEMORRHOIDAL COOLING Gel

Product NDC
43749-450
11-digit product format
437490450
Labeler code
43749
Product ID
43749-450_d1407fe2-f29e-a789-e053-2a95a90a14a0
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl, Witch Hazel
Dosage form
GEL
Route
TOPICAL
Labeler
Unipack, Inc.
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2004-01-01
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL
Active strength
3 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43749-450IInactivated by FDA2026-08-17
excluded packagepackage43749-45043749-450-01IInactivated by FDA2026-08-17

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43749-450-01Avedana HEMORRHOIDAL COOLING Gel1 in 1 CARTONGEL14
43749-450-01Avedana HEMORRHOIDAL COOLING Gel25.5 g in 1 TUBEGEL25.54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43749-450-01GM - Gram43749-45098a07661-ff2e-4263-9aab-dc4677f1233512024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43749-450AVEDANA HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [UNIPACK LLC]4Legacy NDC, 2 package rows20240301_6e7f5b1f-5124-45cd-829d-ed7d940c2b60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
249465phenylephrine HCl 0.25 % / witch hazel 50 % Rectal GelPSN6e7f5b1f-5124-45cd-829d-ed7d940c2b604
249465phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal GelSCD6e7f5b1f-5124-45cd-829d-ed7d940c2b604
249465phenylephrine 0.25 % / witch hazel 50 % Rectal GelSY6e7f5b1f-5124-45cd-829d-ed7d940c2b604

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43749-450-01437490450011 TUBE in 1 CARTON (43749-450-01) > 25.5 g in 1 TUBE1 tube2004-01-010000-00-00NoNoCurrent