Home NDC 0573-2840 Preparation H Cooling Gel
Product NDC 0573-2840
11-digit product format 005732840
Labeler code 0573
Product ID 0573-2840_15581b30-e802-550a-e063-6394a90a3aae
Type HUMAN OTC DRUG
Nonproprietary name phenylephrine hcl, witch hazel
Dosage form GEL
Route TOPICAL
Labeler Haleon US Holdings LLC
Application M015
Marketing category OTC MONOGRAPH DRUG
Marketing start 2004-01-01
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 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, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0573-2840-10 fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0573-2840-20 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0573-2840-10 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0573-2840-20 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0573-2840-10 bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0573-2840-20 bd6a592717d7…303034d00443…
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 Preparation H Cooling Gel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/g WITCH HAZEL 500 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup 101I4J0U34 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 249465 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0573-2840-10 Preparation H Cooling Gel 26 g in 1 TUBE GEL 26 9 0573-2840-10 Preparation H Cooling Gel 1 in 1 CARTON GEL 1 9 0573-2840-20 Preparation H Cooling Gel 1 in 1 CARTON GEL 1 9 0573-2840-20 Preparation H Cooling Gel 51 g in 1 TUBE GEL 51 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0573-2840 PREPARATION H COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [HALEON US HOLDINGS LLC] 9 Current NDC, Legacy NDC, 4 package rows 20240406_cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4.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 21 of 22 · 438 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mayinglong Hemorrhoidal PETROLATUM, ZINC OXIDE Mayinglong Pharmaceutical Group Co., Ltd. b14192ea-1bf7-da6a-e053-2a95a90a5b5e 2023-12-08 Warnings Exact identifier application number: M015 Hemorrhoidal cooling gel PHENYLEPHRINE HCL, WITCH HAZEL WALGREENS 03bbe258-e00d-13cc-e063-6394a90ae345 2023-12-05 Warnings Exact identifier application number: M015 Hemorrhoidal Pain Relief MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL WALGREENS 03bc5c1a-d493-5082-e063-6394a90ae87b 2023-12-05 Warnings Exact identifier application number: M015 Bloop Hemorrhoid Relief Topical GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL Three Nations Corp 0b6419e3-f1c7-bdfe-e063-6294a90a5d92 2023-11-30 Warnings Exact identifier application number: M015 Bloop Fissure Healing Anorectal Topical LIDOCAINE Three Nations Corp 0b645092-ebc4-e4bb-e063-6294a90ad4cf 2023-11-30 Warnings Exact identifier application number: M015 SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEF LIDOCAINE ALPHA PLANTS INC 79fa4b89-382f-45fa-a792-90a9fe5bf573 2023-11-11 Warnings Exact identifier application number: M015 BODY ACTION PRODUCTS Prolong Lubricating BENZOCAINE PRODUCT MAX GROUP INC 3bef5915-1c98-4011-baa9-ad0bbef200c2 2023-11-10 Warnings Exact identifier application number: M015 BODY ACTION PRODUCTS Butt Eze Benzocaine BENZOCAINE PRODUCT MAX GROUP INC ba75b129-7939-4373-91f5-1772976e6d61 2023-11-10 Warnings Exact identifier application number: M015 Uber Numb Topical Anesthetic LIDOCAINE HYDROCHLORIDE UberScientific, LLC 441c802f-a363-1530-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M015 Uber Numb Topical Anesthetic LIDOCAINE HYDROCHLORIDE UberScientific, LLC 4939a547-c94b-3350-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M015 DR REAL NUMB Topical Anorectal LIDOCAINE FUZZYLULU LLC 378d8edc-2120-416d-854c-8881c2950efe 2023-11-09 Warnings Exact identifier application number: M015 The Pharma C Company Medicated Foam with Witch Hazel WITCH HAZEL Kleen Test Products Corporation 1a1fbe83-be45-4654-a7bb-e934e1ccd0c6 2023-11-09 Warnings Exact identifier application number: M015 The Pharma-C Company Medicated Hemorrhoidal Pads WITCH HAZEL Kleen Test Products Corporation 357703ab-4e7a-41f6-9ecf-aa98acc2d92e 2023-11-09 Warnings Exact identifier application number: M015 DOCTORS TOUCH Erase The Pain Lidocaine LIDOCAINE HYDROCHLORIDE DOCTOR'S CHOICE MEDICAL, LLC 3dc9947b-8196-4a38-97b4-c2340ee77e0f 2023-11-06 Warnings Exact identifier application number: M015 SCALAR Pain Relief Cream MENTHOL Miracle Balance, LLC 52a13cfe-3f46-45f8-a5af-ce07ea5758e3 2023-11-06 Warnings Exact identifier application number: M015 SIMPLE PROMISE Simple H Hemorrhoid Relief Cream PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE SIMPLE PROMISE PTE LTD f6622caa-3b31-9b07-e053-2a95a90a8a51 2023-11-06 Warnings Exact identifier application number: M015 WAXUP Numbing LIDOCAINE HYDROCHLORIDE CONSTRUSOLUTION, LLC 4f1645ab-1b19-4d69-99c3-9ea275b01a87 2023-11-06 Warnings Exact identifier application number: M015 SECONDARY NUMB Lidocaine Phenylephrine Gel LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE LALANI Rx Consulting, Inc. 0f13f7b5-e3b1-451e-a6d6-e7e15bd04443 2023-11-06 Warnings Exact identifier application number: M015 Brazzers Anal Desensitizing LIDOCAINE Metro Media Ent ceacd80c-0dd6-4e21-97da-56da877b1c90 2023-11-06 Warnings Exact identifier application number: M015 NUMB PLUS Maximum Strength Anorectal LIDOCAINE SEENEXT VENTURE LTD a7c37b2a-b647-43d7-b43b-87bbece35430 2023-11-05 Warnings Exact identifier application number: M015
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0573-2840-10 00573284010 1 TUBE in 1 CARTON (0573-2840-10) / 26 g in 1 TUBE 1 tube 2004-01-01 0000-00-00 No No Current 0573-2840-20 00573284020 1 TUBE in 1 CARTON (0573-2840-20) / 51 g in 1 TUBE 1 tube 2004-01-01 0000-00-00 No No Current