FDA.reportPublic FDA data

Hemorrhoidal cooling gel

Product NDC
0363-9712
11-digit product format
003639712
Labeler code
0363
Product ID
0363-9712_0bbdecbd-91ce-600d-e063-6294a90a4ca4
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl, Witch hazel
Dosage form
GEL
Route
TOPICAL
Labeler
WALGREENS
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-15
Substance
PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL
Active strength
2.5; 500 mg/g; mg/g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hemorrhoidal cooling gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g
WITCH HAZEL500 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ, 101I4J0U34
Rxcui249465

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9712-01Hemorrhoidal cooling gel1 in 1 CARTONGEL12
0363-9712-01Hemorrhoidal cooling gel26 g in 1 TUBEGEL262

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9712HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREENS]2Current NDC, 2 package rows20240115_03bbe258-e00d-13cc-e063-6394a90ae345.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
249465phenylephrine HCl 0.25 % / witch hazel 50 % Rectal GelPSN03bbe258-e00d-13cc-e063-6394a90ae3452
249465phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal GelSCD03bbe258-e00d-13cc-e063-6394a90ae3452
249465phenylephrine 0.25 % / witch hazel 50 % Rectal GelSY03bbe258-e00d-13cc-e063-6394a90ae3452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9712-01003639712011 TUBE in 1 CARTON (0363-9712-01) / 26 g in 1 TUBE1 tube2024-01-15NoNoHistorical