Home NDC 69396-032 Hemorroidal Cooling gel
Product NDC 69396-032
11-digit product format 693960032
Labeler code 69396
Product ID 69396-032_298d9e2d-7fff-7f15-e063-6394a90a1639
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine, Witch Hazel
Dosage form GEL
Route TOPICAL
Labeler Trifecta Pharmaceuticals Usa Llc
Application M015
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-02-13
Substance WITCH HAZEL; PHENYLEPHRINE HYDROCHLORIDE
Active strength .5; .25 g/100g; g/100g
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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Hemorroidal Cooling gel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength WITCH HAZEL .5 g/100g PHENYLEPHRINE HYDROCHLORIDE .25 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 101I4J0U34 Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69396-032-18 Hemorroidal Cooling gel 56 g in 1 TUBE GEL 56 6 69396-032-18 Hemorroidal Cooling gel 1 in 1 BOX GEL 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69396-032 HEMORROIDAL COOLING GEL (PHENYLEPHRINE, WITCH HAZEL) GEL [TRIFECTA PHARMACEUTICALS USA LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241220_651c0143-384c-3649-e053-2991aa0a0f28.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 23 of 23 · 441 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zensa Numbing Gel LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25% Alera Skin Care Products Inc. 065a6eec-3896-0da8-e063-6394a90a849d 2023-09-27 Warnings Exact identifier application number: M015
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69396-032-18 69396003218 1 TUBE in 1 BOX (69396-032-18) / 56 g in 1 TUBE 1 tube 2018-02-13 0000-00-00 No No Current