FDA.reportPublic FDA data

HEB HEMORRHOIDAL COOLING Gel

Product NDC
37808-993
Requested package NDC
37808-993-24
11-digit product format
378080993
Labeler code
37808
Product ID
37808-993_cad6183e-2503-4cc9-904a-b7358fef652c
Type
HUMAN OTC DRUG
Nonproprietary name
WITCH HAZEL and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
HEB
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-10-18
Marketing end
0000-00-00
Substance
WITCH HAZEL; PHENYLEPHRINE HYDROCHLORIDE
Active strength
1 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage37808-99337808-993-24IInactivated by FDA2026-10-15

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-993-242025-01-30C16284748780-12cef2736-ab7f-d83d-e063-dadaa90ab31fHEB HEMORRHOIDAL COOLING GEL TOPICAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-993-24HEB HEMORRHOIDAL COOLING Gel26 g in 1 TUBECREAM261
37808-993-24HEB HEMORRHOIDAL COOLING Gel1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-993HEB HEMORRHOIDAL COOLING GEL (WITCH HAZEL AND PHENYLEPHRINE HYDROCHLORIDE) CREAM [HEB]1Legacy NDC, 2 package rows20181025_01c320f4-a7f6-4900-91ba-5334a213848b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
249465phenylephrine HCl 0.25 % / witch hazel 50 % Rectal GelPSN01c320f4-a7f6-4900-91ba-5334a213848b1
249465phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal GelSCD01c320f4-a7f6-4900-91ba-5334a213848b1
249465phenylephrine 0.25 % / witch hazel 50 % Rectal GelSY01c320f4-a7f6-4900-91ba-5334a213848b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-993-24378080993241 TUBE in 1 CARTON (37808-993-24) > 26 g in 1 TUBE1 tube2018-10-180000-00-00NoNoCurrent