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…
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 1 of 22 · 436 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dude Hemorrhoidal Wipes WITCH HAZEL Dude Products fdf408ef-9392-a812-e053-6394a90a0017 2026-08-25 Warnings Exact identifier application number: M015 Norms Medicated Wipes WITCH HAZEL Totally Normal Company 3a78e109-3f7c-fb19-e063-6394a90ae78e 2026-08-22 Warnings Exact identifier application number: M015 NERANTE Numbing Cream LIDOCAINE Guangdong Quadrant Ecological Technology Co., Ltd. 4dacd4f1-24d8-37ab-e063-6294a90a944d 2026-08-21 Warnings Exact identifier application number: M015 Lidocaine Numbing Cream LIDOCAINE Shanghai Chuangshi Medical Technology (Group) Co., Ltd. 599b425a-0e96-76df-e063-6394a90a48ff 2026-08-21 Warnings Exact identifier application number: M015 Numb520Spray LIDOCAINE, PHENYLEPHRINE HCL Ebanel Laboratories, Inc. 350f0e25-fbdc-c0c0-e063-6294a90a50a0 2026-08-20 Warnings Exact identifier application number: M015 Flushable Hemorrhoidal Medicated Wipes Maximum Strength WITCH HAZEL Amazon.com Services LLC 41d756f3-e523-ed14-e063-6394a90ab817 2026-08-18 Warnings, Adverse reactions Exact identifier application number: M015 Gembooxt Topical Numbing Cream LIDOCAINE Guangdong Quadrant Ecological Technology Co., Ltd. 49951a3e-3b62-3d66-e063-6294a90a9360 2026-08-12 Warnings Exact identifier application number: M015 NumbMD Lidocaine Cream Anorectal(hemorrhoidal) LIDOCAINE 5% EveryMarket Inc 52379055-d017-4d98-e063-6294a90a196c 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD Lidocaine Cream LIDOCAINE 5% EveryMarket Inc 52369a41-820d-cd7a-e063-6394a90ac6d1 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD Lidocaine Cream LIDOCAINE 5% EveryMarket Inc 51d370b4-1c34-d203-e063-6394a90a80b1 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD 5% Lidocaine cream LIDOCAINE 5% EveryMarket Inc 507d0c2c-9517-40f8-e063-6394a90a1996 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal) LIDOCAINE CREAM ANORECTAL EveryMarket Inc 483d81a3-7493-3391-e063-6394a90a2e3d 2026-08-12 Warnings Exact identifier application number: M015 Numbing Cream LIDOCAINE 100 KARMA INC 35b5ba9d-da1d-55d6-e063-6294a90a5fa8 2026-08-12 Warnings Exact identifier application number: M015 Treatonic hemorrhoid treatment 5% LIDOCAINE 100 KARMA INC 41442fa7-c511-07ca-e063-6294a90a3992 2026-08-12 Warnings Exact identifier application number: M015 Lidocaine numbing cream 5% LIDOCAINE 100 KARMA INC 47380721-6633-4a50-e063-6394a90aca94 2026-08-12 Warnings Exact identifier application number: M015 Treatonic 5% Lidocaine Cream 5% LIDOCAINE CREAM 100 KARMA INC 47dc7630-9a74-1989-e063-6294a90a50bb 2026-08-12 Warnings Exact identifier application number: M015 Treatonic 5% Lidocaine Cream 5% LIDOCAINE CREAM 100 KARMA INC 49e6b69f-bd6e-b415-e063-6394a90a8e65 2026-08-12 Warnings Exact identifier application number: M015 Gniby LIDOCAINE ANORECTAL HEMORRHOIDAL Numbing LIDOCAINE Putian Licheng District Zhijiancheng Trading Co., Ltd. 4a7be9eb-5e57-90e8-e063-6394a90aad9e 2026-08-08 Warnings Exact identifier application number: M015 THE SOLU TION LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE HYDROCHLORIDE SCALP TECH INC 58793581-8826-9a74-e063-6294a90a2465 2026-08-06 Warnings Exact identifier application number: M015 Lidocaine Numbing Cream LIDOCAINE Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. 5457b3d7-e6b6-34a7-e063-6394a90aa240 2026-08-03 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