Cooling Gel

Product NDC: 13709-354
11-digit product format: 137090354
Labeler code: 13709
Product ID: 13709-354_49fb637b-ecc6-1f9b-e063-6294a90ab41a
Type: HUMAN OTC DRUG
Nonproprietary name: Pain Relief Cooling Gel
Dosage form: GEL
Route: TOPICAL
Labeler: NeilMed Pharmaceuticals Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-02-04
Substance: WITCH HAZEL; PHENYLEPHRINE
Active strength: 500; 2.5 mg/g; mg/g
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Cooling Gel
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
WITCH HAZEL	500 mg/g
PHENYLEPHRINE	2.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
101I4J0U34	Internal UNII lookup
1WS297W6MV	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
49fb637b-ecc5-1f9b-e063-6294a90ab41a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13709-354-01	Cooling Gel	25.5 g in 1 TUBE	GEL	25.5		1
13709-354-01	Cooling Gel	1 in 1 CARTON	GEL	1		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 91 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEEL PAIN Relief Gel Roll-On	MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	36bacb5f-c1af-2e97-e063-6394a90afe5c	2025-06-04	Warnings	Exact identifier application number: M017
Capsaicin 0.075% Cream	CAPSAICIN	ViolaCare, Inc.	30911225-a6d7-4b2b-9005-b733373e2877	2025-06-04	Warnings	Exact identifier application number: M017
LidoGuard	LIDOCAINE HCL	ViolaCare, Inc.	531383aa-4f0f-4fe0-91f4-d809b39f160f	2025-06-04	Warnings	Exact identifier application number: M017
HealthWise Lidocaine and Menthol	LIDOCAINE AND MENTHOL	Veridian Healthcare	36c27642-f913-1aad-e063-6294a90a4343	2025-06-04	Warnings	Exact identifier application number: M017
HealthWise Ultra OTC Strength Pain Relief Cream	CAMPHOR, MENTHOL, AND METHYL SALICYLATE	Veridian Healthcare	36c3bbf9-a559-4c0d-e063-6394a90a8a1a	2025-06-04	Warnings	Exact identifier application number: M017
Everlight Survival Sting Relief Pad	BENZOCAINE	Yiwu Ori-Power Medtech Co.,Ltd.	364c9882-339e-fe22-e063-6294a90a37f4	2025-06-04	Warnings	Exact identifier application number: M017
LIGHTS Sting Relief Prep Pad	BENZOCAINE	Lights Medical Manufacture Co., Ltd.	4f4d7758-be62-4304-8871-087a90497fa5	2025-06-04	Warnings	Exact identifier application number: M017
Elsophie Nicotine Patches Quit	NICOTINE PATCHES QUIT SMOKING	Shenzhen Xinxin Yunhai Technology Co., Ltd.	36b63da9-94cc-b52a-e063-6394a90a5029	2025-06-03	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE HYDROCHLORIDE	J&A Digital Inc.	d4b09055-b93e-466f-9e24-cae098af6e24	2025-06-02	Warnings	Exact identifier application number: M017
RE-LEVE	MENTHOL	SOMBRA COSMETICS INC.	b4b39d79-0439-41e7-adca-e5ccb8f44e40	2025-05-29	Warnings	Exact identifier application number: M017
PAIN NO MORE THERAPY	MENTHOL CAMPHOR	SOMBRA COSMETICS INC.	f7bacc8e-6a8b-4cd8-bd0e-68890bee5818	2025-05-29	Warnings	Exact identifier application number: M017
DermaD ANTI-ITCH Therapeutic	SALICYLIC ACID	Chen Cohen Industries Inc.	8f4a57cb-0a5b-42b0-a325-1f92f3942ad9	2025-05-29	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	f7aecfb4-c194-4554-8d05-4e46005e654b	2025-05-27	Warnings	Exact identifier application number: M017
RockSauce Warming Massage	MENTHOL, METHYL SALICYLATE	Nantong Health & Beyond Hygienic Products Inc.	b679ed7b-9d88-4eff-9743-567affe0fe2b	2025-05-27	Warnings	Exact identifier application number: M017
RockSauce Warming Massage Roll On	MENTHOL, METHYL SALICYLATE	Nantong Health & Beyond Hygienic Products Inc.	28eb8273-5789-4f33-bbbe-3a5ec7bc7929	2025-05-27	Warnings	Exact identifier application number: M017
AUVON Pain Relief Cream	LIDOCAINE	SHENZHEN YUWEN E-COMMERCE CO., LTD.	358c2632-3b90-1c54-e063-6294a90ad461	2025-05-22	Warnings	Exact identifier application number: M017
WelAhead by Welmate Lidocaine 5% Roll-on	LIDOCAINE 5%	OTC PHARM LLC	0b75e83e-8c7b-6247-e063-6294a90ac413	2025-05-21	Warnings	Exact identifier application number: M017
Bliss Republic	LIDOCAINE NUMBING EXTRA STRENGTH CREAM	Sargass Group Limited Liability Company	35aba13a-95e6-a395-e063-6294a90a5bdc	2025-05-21	Warnings	Exact identifier application number: M017
Xpect Stopain Clinical	MENTHOL	Cintas Corporation	e911478f-7153-4700-b945-92ec54972f45	2025-05-21	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Preferred Pharmaceuticals Inc.	0976a898-8d79-4b85-b473-c8ad32b4fd00	2025-05-20	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
101I4J0U34	WITCH HAZEL		WITCH HAZEL
1WS297W6MV	PHENYLEPHRINE	59-42-7	PHENYLEPHRINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
249465	phenylephrine HCl 0.25 % / witch hazel 50 % Rectal Gel	PSN	49fb637b-ecc5-1f9b-e063-6294a90ab41a	1
249465	phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal Gel	SCD	49fb637b-ecc5-1f9b-e063-6294a90ab41a	1
249465	phenylephrine 0.25 % / witch hazel 50 % Rectal Gel	SY	49fb637b-ecc5-1f9b-e063-6294a90ab41a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
13709-354-01	13709035401	1 TUBE in 1 CARTON (13709-354-01) / 25.5 g in 1 TUBE	1 tube	2026-02-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cooling Gel	NeilMed Pharmaceuticals Inc. \| NeilMed Pharmaceuticals Inc	2026-02-04	HUMAN OTC DRUG LABEL	1