Cooling Gel
- Product NDC
- 13709-346
- Requested package NDC
- 13709-346-01
- 11-digit product format
- 137090346
- Labeler code
- 13709
- Product ID
- 13709-346_43754077-b81a-1a34-e063-6294a90a1712
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pain Relief Cooling Gel
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Neilmed Pharmaceuticals Inc.
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-11-13
- Substance
- PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL
- Active strength
- 2.5; 505 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
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 13709-346 | 13709-346-01 | D | Discontinued by firm | 2026-07-31 |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream | LIDOCAINE | Guangdong Aimu Biological Technology Co., Ltd | 578fa642-ff30-e511-e063-6294a90a5987 | 2026-07-26 | Warnings | M015 |
| CVS Topical Anesthetic Hemorrhoidal | DIBUCAINE | CVS PHARMACY, INC | 9f3d4fdb-ad82-4ab8-8a9e-252d027068ab | 2026-07-25 | Warnings | M015 |
| Moisture Barrier | MENTHOL 0.44%, ZINC OXIDE 20.6% | Walgreen Company | 258f3392-0f42-21e8-e063-6294a90ae9ad | 2026-07-22 | Warnings | M015 |
| RectaEase Hemorrhoid Relief Cream | LIDOCAINE | Trifecta Pharmaceuticals USA LLC | c054921a-9f1b-7c75-e053-2995a90a1738 | 2026-07-20 | Warnings | M015 |
| Lidocaine Numbing Cream | LIDOCAINE | KORVIA GLOBAL Inc. | 5690db03-4d62-9660-e063-6394a90a2fc0 | 2026-07-14 | Warnings | M015 |
| Gembooxt Topical Numbing Cream | LIDOCAINE HCL | Guangdong Quadrant Ecological Technology Co., Ltd. | 49951a3e-3b62-3d66-e063-6294a90a9360 | 2026-07-13 | Warnings | M015 |
| Zmztuhua Numbing Cream | LIDOCAINE | Guangzhou Hechuang Commercial Service Co.,Ltd. | 56417dc6-c14b-ad17-e063-6294a90af7e5 | 2026-07-10 | Warnings | M015 |
| Tina Davies IceCream | LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE | TINA DAVIES PROFESSIONAL LLC | 6a2b3199-f405-4455-9a02-8885d24eef9c | 2026-07-09 | Warnings | M015 |
| Drs pharmacy HEMORRHOIDAL | PHENYLEPHRINE HCL, WITCH HAZEL | OL PHARMA TECH, LLC Drs PHARMACY | 164169b9-0627-9d1a-e063-6294a90ac46d | 2026-07-09 | Warnings | M015 |
| Witch Hazel | WITCH HAZEL | H E B | 09b814f4-86b5-4810-bf52-cc88396451c2 | 2026-07-07 | Warnings, Adverse reactions | M015 |
| Witch Hazel | WITCH HAZEL | ADUSA Distribution, LLC | c50d0496-6f09-43c2-9383-3250885968c9 | 2026-06-29 | Warnings, Adverse reactions | M015 |
| Adellina Lidocaine Numbing Cream Topical Anorectal Cream | LIDOCAINE | Guangdong Aimu Biological Technology Co., Ltd | 55260a3e-637a-c53b-e063-6394a90a1b09 | 2026-06-27 | Warnings | M015 |
| Walgreens Hemorrhoidal | HEMORRHOIDAL RECTAL SUPPOSITORIES | Walgreens | 20c41406-99b2-bc89-e063-6294a90aed73 | 2026-06-25 | Warnings | M015 |
| CalaSoothe | CALAMINE, MENTHOL, AND ZINC OXIDE | Dynarex Corporation | 54f12005-acfe-4821-e063-6394a90ac304 | 2026-06-24 | Warnings | M015 |
| tina davies IceCream Hemorrhoidal | LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE | TINA DAVIES PROFESSIONAL LLC | 10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd | 2026-06-24 | Warnings | M015 |
| Haemorrhoidal Pain Relief | ANORECTAL CREAM | NeilMed Pharmaceuticals Inc | 544a9d6f-4eaa-613e-e063-6294a90a0c50 | 2026-06-15 | Warnings | M015 |
| Lidocaine Numbing Cream | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 5457b3d7-e6b6-34a7-e063-6394a90aa240 | 2026-06-15 | Warnings | M015 |
| Dr.Seymour Butts Hemorrhoid | LIDOCAINE5% PHENYLEPHRINE HCL 0.25% HEMORRHOID | Jiangxi Yudexi Pharmaceutical Co., LTD | 4981c7d9-53ee-2a7b-e063-6394a90add01 | 2026-06-12 | Warnings | M015 |
| ANIXIKE Numbing | LIDOCAINE4% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4d5b7c4c-feac-4eeb-e063-6294a90a5748 | 2026-06-11 | Warnings | M015 |
| tina davies IceJelly Hemorrhoidal | LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE | TINA DAVIES PROFESSIONAL LLC | 580559bf-d91f-4bb3-9c9b-b7e2cd0686fd | 2026-06-11 | Warnings | M015 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13709-346-01 | Cooling Gel | 25.5 g in 1 TUBE | GEL | 25.5 | 1 | |
| 13709-346-01 | Cooling Gel | 1 in 1 CARTON | GEL | 1 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2727426 | phenylephrine HCl 0.25 % / witch hazel 50.5 % Rectal Gel | PSN | 43754077-b819-1a34-e063-6294a90a1712 | 1 |
| 2727426 | phenylephrine hydrochloride 0.0025 MG/MG / witch hazel 0.505 MG/MG Rectal Gel | SCD | 43754077-b819-1a34-e063-6294a90a1712 | 1 |
| 2727426 | phenylephrine hydrochloride 0.25 % / witch hazel 50.5 % Rectal Gel | SY | 43754077-b819-1a34-e063-6294a90a1712 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 13709-346-01 | 13709034601 | 1 TUBE in 1 CARTON (13709-346-01) / 25.5 g in 1 TUBE | 1 tube | 2025-11-13 | No | No | Historical |