Hemorrhoidal Cooling

Product NDC
0363-0843
11-digit product format
003630843
Labeler code
0363
Product ID
0363-0843_ce140374-4b4b-445d-a29c-b0b3bac49a6e
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl, Witch hazel
Dosage form
GEL
Route
TOPICAL
Labeler
Walgreen Company
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-07-19
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL
Active strength
0 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct0363-0843DDiscontinued by firm2026-10-05
excluded packagepackage0363-08430363-0843-01DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-0843-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-0843-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-0843-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-0843-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-0843-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-0843-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0843-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0843-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0843-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-0843-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0363-0843-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0363-0843-01557ba5c1ecfa…9c80585c8c6e…

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
0363-0843-01GM - Gram0363-08439fc947a2-1476-49b5-b554-e683447c00eb12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREEN COMPANY]3
WITCH HAZELACTIVE INGREDIENT101I4J0U34HEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREEN COMPANY]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREEN COMPANY]3
WITCH HAZELACTIVE MOIETY101I4J0U34HEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREEN COMPANY]3
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1HEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREEN COMPANY]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREEN COMPANY]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREEN COMPANY]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREEN COMPANY]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREEN COMPANY]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREEN COMPANY]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREEN COMPANY]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRHEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREEN COMPANY]3
SULISOBENZONEINACTIVE INGREDIENT1W6L629B4KHEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREEN COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RHEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREEN COMPANY]3