Bite and Itch

Product NDC: 11383-192
11-digit product format: 113830192
Labeler code: 11383
Product ID: 11383-192_28650b5a-ed6f-199c-e063-6394a90a9dac
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride, Pramoxine Hydrochloride
Dosage form: LOTION
Route: CUTANEOUS
Labeler: Weeks & Leo Co., Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-06-15
Substance: PRAMOXINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 1; 2 g/100mL; g/100mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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: Bite and Itch
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	1 g/100mL
DIPHENHYDRAMINE HYDROCHLORIDE	2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
88AYB867L5	Internal UNII lookup
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1292321	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
0a4d471b-c3f3-0a6a-e063-6394a90ad57b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	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	SPL version
11383-192-01	Bite and Itch	118 mL in 1 BOTTLE	LOTION	118	3
11383-192-01	Bite and Itch	1 in 1 CARTON	LOTION	1	3
11383-192-04	Bite and Itch	118 mL in 1 BOTTLE	LOTION	118	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11383-192	BITE AND ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE) LOTION [WEEKS & LEO CO., INC.]	3	Current NDC, 3 package rows	20241206_0a4d471b-c3f3-0a6a-e063-6394a90ad57b.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 34 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET PAIN RELIEF	4a7f92d3-dd35-44a3-e063-6294a90ae004	2026-02-10	Warnings	Exact identifier application number: M017
NICOVITO HEMORRHOID MASTER	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTER	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5e24fa-959e-79b4-e063-6294a90a8f68	2026-02-09	Warnings	Exact identifier application number: M017
Tiger Balm Active Muscle Rub	METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)	Haw Par Healthcare Ltd.	2e7638c6-e1ce-4e2f-bd50-52fbce5a138e	2026-02-09	Warnings	Exact identifier application number: M017
Tiger Balm Neck and Shoulder Rub	CAMPHOR (SYNTHETIC) AND MENTHOL	Haw Par Healthcare Ltd.	2f272d12-7b34-430e-817e-1005f57ed9e9	2026-02-09	Warnings	Exact identifier application number: M017
Welmate Lidocaine Pain Relieving Patch	LIDOCAINE	YYBA CORP	4303fd30-0d35-3671-e063-6394a90a2aee	2026-02-09	Warnings	Exact identifier application number: M017
Pain Relief Lidocaine	LIDOCAINE	Kroger Company	4098756e-3d9f-317a-e063-6394a90af04c	2026-02-09	Warnings	Exact identifier application number: M017
Aquanil HC	HYDROCORTISONE	Person and Covey	4a698246-05a6-d01f-e063-6294a90a3401	2026-02-09	Warnings	Exact identifier application number: M017
Hemorrhoid Master	LIDOCAINE, PHENYLEPHRINE	Ebanel Laboratories, Inc	41292d65-dabe-4bc3-872f-34a3912aa342	2026-02-09	Warnings	Exact identifier application number: M017
DERMFREE NEUROPATHY	ARNICA MONTANA 1X HPUS 7% NEUROPATHY	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5c232d-5d29-2504-e063-6394a90ac9de	2026-02-08	Warnings	Exact identifier application number: M017
ASSIELF NUMBING Topical Anorectal	LIDOCAINE	Shenzhen Yuanbang International Logistics Co., Ltd	4a5cb477-57ef-2a1d-e063-6394a90ac9ed	2026-02-08	Warnings	Exact identifier application number: M017
Lidocaine Pain Relieve Gel-Patch	PAIN RELIEVE GEL-PATCH	Henan Kangdi Medical Devices Co., Ltd	1e31b950-e990-e255-e063-6394a90a7d23	2026-02-07	Warnings	Exact identifier application number: M017
Herbal Knee Patch	HERBAL KNEE PATCH	Henan Kangdi Medical Devices Co., Ltd	2a009059-b515-8214-e063-6294a90a4ed3	2026-02-07	Warnings	Exact identifier application number: M017
Flocean ANTI-ITCH	BENZOCAINE 5%ANTI-ITCH	Jiangxi Yudexi Pharmaceutical Co., LTD	4a493911-a846-5aa0-e063-6294a90a65ac	2026-02-07	Warnings	Exact identifier application number: M017
daily solutions Ice Blue Analgesic	MENTHOL, UNSPECIFIED FORM	Garcoa, Inc.	4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e6	2026-02-06	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Shenzhen Wankelai E-commerce Co., Ltd.	4a22562b-601e-97d7-e063-6394a90a5bca	2026-02-06	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Sportpharm LLC	ee64ad1e-78db-4553-a3cf-b539b770fa26	2026-02-06	Warnings	Exact identifier application number: M017
Pain Relief Gel-Patch	LIDOCAINE 4%	Sportpharm LLC	1dd022b9-88ae-4737-88cc-fdb0ce0a83a3	2026-02-06	Warnings	Exact identifier application number: M017
Camphor plus Lidocaine Pain Relief	CAMPHOR, LIDOCAINE	Veridian Healthcare	4a2b73a8-c10c-85f9-e063-6294a90ac52c	2026-02-06	Warnings	Exact identifier application number: M017
Aloe Vera Gel	LIDOCAINE HCL, MENTHOL	Retail Business Services, LLC	073c72fe-3171-4a4f-913a-d1b9630a1af3	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M017
HealthWise Soothing Lidocaine Pain Relief	LIDOCAINE HCI 0.5%	Veridian Healthcare	4a2ec73e-7332-6f13-e063-6294a90a8506	2026-02-06	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1292321	diphenhydrAMINE HCl 2 % / pramoxine HCl 1 % Topical Lotion	PSN	0a4d471b-c3f3-0a6a-e063-6394a90ad57b	3
1292321	diphenhydramine hydrochloride 20 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion	SCD	0a4d471b-c3f3-0a6a-e063-6394a90ad57b	3
1292321	diphenhydramine hydrochloride 2 % / pramoxine hydrochloride 1 % Topical Lotion	SY	0a4d471b-c3f3-0a6a-e063-6394a90ad57b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
11383-192-01	11383019201	1 BOTTLE in 1 CARTON (11383-192-01) / 118 mL in 1 BOTTLE	1 bottle	2015-06-15	No	No	Current
11383-192-04	11383019204	118 mL in 1 BOTTLE (11383-192-04)	118 ml	2015-06-15	No	No	Current