Home NDC 42507-944 Hemorrhoidal
Product NDC 42507-944
11-digit product format 425070944
Labeler code 42507
Product ID 42507-944_cfe1c8bb-b48e-4329-8c1b-b93e75b02d56
Type HUMAN OTC DRUG
Nonproprietary name glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum
Dosage form CREAM
Route TOPICAL
Labeler HyVee Inc
Application M015
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-08-11
Substance GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM
Active strength 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 24 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42507-944-24 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42507-944-24 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42507-944-24 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42507-944-24 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42507-944-24 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42507-944-24 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42507-944-24 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42507-944-24 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42507-944-24 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42507-944-24 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42507-944-24 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42507-944-24 557ba5c1ecfa…9c80585c8c6e…
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 Hemorrhoidal
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCERIN 14.4 g/100g PHENYLEPHRINE HYDROCHLORIDE .25 g/100g PRAMOXINE HYDROCHLORIDE 1 g/100g PETROLATUM 15 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1293649 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GLYCERIN ACTIVE INGREDIENT PDC6A3C0OX HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 PETROLATUM ACTIVE INGREDIENT 4T6H12BN9U HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 PRAMOXINE HYDROCHLORIDE ACTIVE INGREDIENT 88AYB867L5 HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 GLYCERIN ACTIVE MOIETY PDC6A3C0OX HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 PETROLATUM ACTIVE MOIETY 4T6H12BN9U HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 PRAMOXINE ACTIVE MOIETY 068X84E056 HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 .ALPHA.-TOCOPHEROL INACTIVE INGREDIENT H4N855PNZ1 HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 LAURETH-23 INACTIVE INGREDIENT N72LMW566G HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 PANTHENOL INACTIVE INGREDIENT WV9CM0O67Z HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 PROPYL GALLATE INACTIVE INGREDIENT 8D4SNN7V92 HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 STEARETH-2 INACTIVE INGREDIENT V56DFE46J5 HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 STEARETH-20 INACTIVE INGREDIENT L0Q8IK9E08 HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [HYVEE INC] 1
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 15 of 22 · 438 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BODY ACTION PRODUCTS Anal Glide Extra BENZOCAINE PRODUCT MAX GROUP INC 282ac8d3-2caf-42de-b347-450e9c7a9e50 2025-04-03 Warnings Exact identifier application number: M015 Numb 520 LIDOCAINE Clinical Resolution Laboratory, Inc. 984c4bee-0d44-4e0f-a057-0d54400c4cac 2025-04-02 Warnings Exact identifier application number: M015 hemorrhoidal MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL Bionpharma Inc. 1790da99-2a22-e2a2-e063-6394a90ac36f 2025-03-31 Warnings Exact identifier application number: M015 HemAway LIDOCAINE Melaleuca, Inc. cf842adf-fcd7-2c8c-e053-2995a90adea6 2025-03-27 Warnings Exact identifier application number: M015 Numb and Number Anorectal Cream LIDOCAINE Dermtech Labs, Inc 31420635-5021-173d-e063-6294a90a407a 2025-03-26 Warnings Exact identifier application number: M015 Leader Maximum Strength Hemorrhoidal Relief LIDOCAINE Cardinal Health,Inc. 65c780b0-7f47-4ae9-a847-c22deaaa2888 2025-03-21 Warnings Exact identifier application number: M015 Curist Hemorrhoid Fissure Relief LIDOCAINE Little Pharma, Inc 2fb02b00-acdb-5184-e063-6294a90ae1c8 2025-03-06 Warnings Exact identifier application number: M015 Thera Plus Hemorrhoidal GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE FOURSTAR GROUP USA, INC. 87143a7a-7b2d-4b67-afda-2355697e7300 2025-03-04 Warnings Exact identifier application number: M015 Numbskin Maximum Strength Pain Reliever LIDOCAINE Shinpharma Inc 2f288bde-99fd-42f8-e063-6394a90a0f05 2025-02-27 Warnings Exact identifier application number: M015 PREPARATION H TOTABLES IRRITATION RELIEF WIPES WITCH HAZEL Haleon US Holdings LLC 1953ec64-20ce-488b-8f14-44e15cc9e720 2025-02-21 Warnings Exact identifier application number: M015 LBRI STOP THE PAIN Super Aloe Pain Relief Cream MENTHOL, METHYL SALICYLATE L'BRI HEALTH AND BEAUTY INC 62e18a37-c0db-4b1e-a6a1-35684cc00e08 2025-01-28 Warnings Exact identifier application number: M015 Hemorrhoidal PAIN RELIEF NeilMed Pharmaceuticals Inc. 038a2cf5-1b72-227b-e063-6394a90a84ad 2025-01-24 Warnings Exact identifier application number: M015 lidocaine LIDOCAINE Nivagen Pharmaceuticals, Inc. 32964ec3-1880-477b-9f71-2222c39106aa 2025-01-23 Warnings Exact identifier application number: M015 Hemorrhoidal cocoa butter HEMORRHOIDAL NeilMed Pharmaceuticals Inc. 03b159b0-b960-b38d-e063-6394a90a9462 2025-01-17 Warnings Exact identifier application number: M015 Gentle Laxative Bisacodyl GENTLE LAXATIVE BISACODYL NeilMed Pharmaceuticals Inc 03b3733a-4d78-149f-e063-6294a90a6518 2025-01-17 Warnings Exact identifier application number: M015 Glycerin Laxative GLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEF NeilMed Pharmaceuticals Inc. 03b4be69-6488-76be-e063-6394a90a7edf 2025-01-17 Warnings Exact identifier application number: M015 Pre-moistened Medicated Wipes, Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal Astringent, Walgreens Pre-moistened Medicated Wipes, Walgreens Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal Astringent WITCH HAZEL Walgreens Company 209a111b-d169-cb5d-e063-6394a90a33ca 2025-01-15 Warnings Exact identifier application number: M015 Pre-moistened Medicated Pads, Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch Hazel, Walgreens Pre-moistened Medicated Pads, Walgreens Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch Hazel WITCH HAZEL Walgreens Company 1e2dcec1-a1fe-71d2-e063-6394a90a9908 2025-01-15 Warnings Exact identifier application number: M015 AER Pre-moistened Witch Hazel Pad WITCH HAZEL Birchwood Laboratories LLC 1cca622f-0a6b-4f35-9355-34c249ee705e 2025-01-14 Warnings Exact identifier application number: M015 B-SURE Traveler Towelette B-SURE TRAVELER Birchwood Laboratories LLC e1a5da94-6a1a-497b-a737-1c1541bf0404 2025-01-14 Warnings Exact identifier application number: M015
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42507-944-24 42507094424 1 TUBE in 1 CARTON (42507-944-24) / 51 g in 1 TUBE (42507-944-51) 1 tube 2008-08-11 No No Current