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.
| 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 |
|---|---|
| GLYCERIN | 14.4 g/100g |
| PHENYLEPHRINE HYDROCHLORIDE | .25 g/100g |
| PRAMOXINE HYDROCHLORIDE | 1 g/100g |
| PETROLATUM | 15 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| PDC6A3C0OX | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
| 88AYB867L5 | Internal UNII lookup |
| 4T6H12BN9U | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1293649 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b867f691-7a13-4659-b664-06aa36899310 | Available on FDA.report |
DailyMed Socrata Ingredients#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hemorrhoid, Fissure, ProctalgiaSuppositories | CARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL | WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd. | 1d40d16a-ee52-463a-e063-6394a90a6077 | 2026-01-14 | Warnings | M015 |
| Hemorrhoid, Fissure, Proctalgia Relief Wash | CARBON, PANTHENOL, SODIUM HYALURONATE | WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd. | 1e20de39-45b0-54ec-e063-6294a90a04ed | 2026-01-14 | Warnings | M015 |
| Hemorrhoid, Fissure, Proctalgia Ointments | CARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL, GLYCERIN | WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd. | 1efe43d5-a29b-5cb2-e063-6394a90aca66 | 2026-01-14 | Warnings | M015 |
| LONAZEM | MENTHOL,PETROLATUM | PEER PHARM LTD. | 91f7a741-4178-4639-9cd5-746a4b9a21bf | 2026-01-12 | Warnings | M015 |
| Hemorrhoidal Hygiene pads | WITCH HAZEL | Akron Pharma Inc. | 936a0cca-5049-4ddf-9581-75c2da6d9cfa | 2026-01-12 | Warnings | M015 |
| Signature numbing cream | 5% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 4805ba4e-45d3-bf0a-e063-6294a90a6eef | 2026-01-10 | Warnings | M015 |
| THE SOLUTION 2.0 | LIDOCAINE | SCALP TECH INC | 0fa423b6-cc0f-b569-e063-6294a90a239e | 2026-01-09 | Warnings | M015 |
| BLACK LABEL B NUMB | LIDOCAINE HYDROCHLORIDE | SCALP TECH INC | 11fcf401-0891-04bc-e063-6294a90a8ad5 | 2026-01-09 | Warnings | M015 |
| GOLD LABEL B NUMB | LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE | SCALP TECH INC | 1211590a-13b5-2e75-e063-6394a90a0f86 | 2026-01-09 | Warnings | M015 |
| 0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE | Universal Distribution Center LLC | 90844919-f16a-4390-9dca-b0405b501445 | 2026-01-08 | Warnings | M015 |
| Signature numbing cream | 5% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 47dda425-86d8-441e-e063-6294a90a0f9a | 2026-01-08 | Warnings | M015 |
| AER Traveler Towelette | AER TRAVELER | Birchwood Laboratories LLC | 26556b9b-1c3a-6cf5-e063-6394a90ab26c | 2026-01-08 | Warnings | M015 |
| Preparation H Rapid Relief | GLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 49a93cfc-4ccd-4ef3-928f-901b9926f794 | 2026-01-08 | Warnings | M015 |
| PREPARATION H FOR WOMEN | WITCH HAZEL | Haleon US Holdings LLC | a9099cf4-4e2e-4cf1-a52f-48f8e174cb15 | 2026-01-08 | Warnings | M015 |
| LIPOCAINE 5 | LIDOCAINE 5% | ESBA LABORATORIES INC. | 849d6e28-a6b8-7f49-e053-2a91aa0a497d | 2026-01-08 | Warnings | M015 |
| TOPICAINE 5 | LIDOCAINE 5% | ESBA LABORATORIES INC. | 15d33ff7-34ed-253d-e054-00144ff88e88 | 2026-01-08 | Warnings | M015 |
| Dr Wellskin Numbing Cream | 5% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 47ebedc5-caf1-a774-e063-6394a90ae14d | 2026-01-08 | Warnings | M015 |
| Dr. Care Numbing Cream | LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 47c94198-7718-bbc2-e063-6294a90a48f1 | 2026-01-07 | Warnings | M015 |
| Healthwise Anorectal Pain Relief | LIDOCAINE 5% | Veridian Healthcare | 19c24e1b-a31b-478b-a48b-c39bb4753ca7 | 2026-01-06 | Warnings | M015 |
| Good Sense Hemorrhoidal Maximum Strength Pain Relief | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | L. Perrigo Company | 1d6142b6-3746-46f1-99ec-4b19d26f056e | 2026-01-06 | Warnings | M015 |
Packages#
| 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 |