ITCH X

Product NDC: 0225-0495
11-digit product format: 002250495
Labeler code: 0225
Product ID: 0225-0495_2888be26-0ebc-ab78-e063-6394a90ada63
Type: HUMAN OTC DRUG
Nonproprietary name: BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE
Dosage form: GEL
Route: TOPICAL
Labeler: BF ASCHER AND CO INC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-09-19
Substance: BENZYL ALCOHOL; PRAMOXINE HYDROCHLORIDE
Active strength: 10; 1 g/100g; g/100g
Pharmacologic classes: Pediculicide [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: ITCH X
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZYL ALCOHOL	10 g/100g
PRAMOXINE HYDROCHLORIDE	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LKG8494WBH	Internal UNII lookup
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1293632	Internal RxNorm lookup
1293634	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
03c16d33-8f59-0184-e054-00144ff8d46c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0225-0495-33	ITCH X	35.4 g in 1 TUBE	GEL	35.4		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0225-0495-33	GM - Gram	0225-0495	adf96dec-94ed-41d3-b853-e9b2a1ce7e47	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZYL ALCOHOL	ACTIVE INGREDIENT	LKG8494WBH	ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]	1
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]	1
BENZYL ALCOHOL	ACTIVE MOIETY	LKG8494WBH	ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]	1
PRAMOXINE	ACTIVE MOIETY	068X84E056	ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]	1
ALOE	INACTIVE INGREDIENT	V5VD430YW9	ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]	1
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	Z135WT9208	ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]	1
EDETOL	INACTIVE INGREDIENT	Q4R969U9FR	ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0225-0495	ITCH X (BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE) GEL [BF ASCHER AND CO INC]	6	Current NDC, Legacy NDC, 1 package rows	20241208_03c16d33-8f59-0184-e054-00144ff8d46c.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 143 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sheffield Arthritis and Muscle Pain Relief	CAPSICUM OLEORESIN	Sheffield Pharmaceuticals LLC	724b9870-e86a-4087-ba78-8c944ce3baa6	2023-11-28	Warnings	Exact identifier application number: M017
Dr Sheffield Muscle Rub Cream	MUSCLE RUB CREAM	Sheffield Pharmaceuticals LLC	60d1d826-a53e-42e5-bc30-1b2c2690445b	2023-11-28	Warnings	Exact identifier application number: M017
Thera Plus Cold Therapy Pain Relieving Menthol	MENTHOL	Fourstar Group USA, Inc.	0a462c91-5300-e282-e063-6394a90a4cc2	2023-11-27	Warnings	Exact identifier application number: M017
UtaSpray	MENTHOL AND METHYL SALICYLATE	Big 5 Nutrition LLC	c641ab11-cd00-4e23-ace7-8178739084f0	2023-11-21	Warnings	Exact identifier application number: M017
Top Medicated Oil	CAMPHOR, MENTHOL, METHYL SALICYLATE	Big 5 Nutrition LLC	b2f0d1e1-7d03-434e-be39-9f980459690c	2023-11-21	Warnings	Exact identifier application number: M017
BT Pain Relief Balm	METHYL SALICYLATE, MENTHOL, CAMPHOR	Big 5 Nutrition LLC	50112419-c934-4d3a-9ea6-9b089f516a6d	2023-11-21	Warnings	Exact identifier application number: M017
BT Pain Relief	MENTHOL, METHYL SALICYLATE	Big 5 Nutrition LLC	91324910-27cf-424f-9e9b-6173f2d7acbf	2023-11-21	Warnings	Exact identifier application number: M017
Dit Da Shui	MENTHOL AND METHYL SALICYLATE	Big 5 Nutrition LLC	5d45cb48-3e88-4d58-81d2-6f88d7a82134	2023-11-20	Warnings	Exact identifier application number: M017
Herbal Balm	METHYL SALICYLATE, MENTHOL AND	Big 5 Nutrition LLC	09b3b86d-3434-428b-b0a8-e8dfd7c0b52a	2023-11-20	Warnings	Exact identifier application number: M017
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	BluePoint Laboratories	b505769e-9c46-3cf3-e053-2a95a90a4df9	2023-11-17	Warnings	Exact identifier application number: M017
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	BluePoint Laboratories	d6523993-d781-cdbc-e053-2a95a90af191	2023-11-17	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	4d91baf3-9655-4786-93b8-aa0d93fe0bf9	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE LEG CRAMP	MENTHOL	KOBAYASHI Healthcare International, Inc.	7ef03298-6623-4cf4-b21f-74b2ffc11c6e	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	436e8578-b609-4b45-8f84-0d111140fda6	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL	KOBAYASHI Healthcare International, Inc.	08dcfa78-7332-4f19-90d7-fdd7d446848a	2023-11-16	Warnings	Exact identifier application number: M017
Totally Fun After Sun	LIDOCAINE HCL	MJ Products Association, LLC	965a2a29-914c-4ad0-b25f-5df3c30da393	2023-11-15	Warnings	Exact identifier application number: M017
Universal Ice Cold Analgesic	MENTHOL	Universal Distribution Center LLC	4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f	2023-11-15	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	b44beac3-1d20-434f-9a79-4fab1ac68791	2023-11-15	Warnings	Exact identifier application number: M017
Universal Ice Cold Analgesic	MENTHOL	Universal Distribution Center LLC	79ad55eb-b59d-4bb8-88e3-3b51e10a7f28	2023-11-15	Warnings	Exact identifier application number: M017
PURE EASE Joint Muscle lnstant Pain Relief	CAPSAICIN, MENTHOL	SERENU, INC.	42bf129c-5c84-4331-b6d0-78e3be71a985	2023-11-13	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LKG8494WBH	BENZYL ALCOHOL	100-51-6	BENZYL ALCOHOL
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1293634	Itch-X 10 % / 1 % Topical Gel	PSN	03c16d33-8f59-0184-e054-00144ff8d46c	6
1293632	pramoxine HCl 1 % / benzyl alcohol 10 % Topical Gel	PSN	03c16d33-8f59-0184-e054-00144ff8d46c	6
1293634	benzyl alcohol 0.1 ML/ML / pramoxine hydrochloride 0.01 MG/MG Topical Gel [Itch-X]	SBD	03c16d33-8f59-0184-e054-00144ff8d46c	6
1293632	benzyl alcohol 0.1 ML/ML / pramoxine hydrochloride 0.01 MG/MG Topical Gel	SCD	03c16d33-8f59-0184-e054-00144ff8d46c	6
1293632	benzyl alcohol 10 % / pramoxine hydrochloride 1 % Topical Gel	SY	03c16d33-8f59-0184-e054-00144ff8d46c	6
1293634	Itch-X (benzyl alcohol 10 % / pramoxine hydrochloride 1 % ) Topical Gel	SY	03c16d33-8f59-0184-e054-00144ff8d46c	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0225-0495-33	00225049533	35.4 g in 1 TUBE (0225-0495-33)	35.4 g	2014-09-19	0000-00-00	No	No	Current