QC Medicated anti itch

Product NDC: 63868-959
11-digit product format: 638680959
Labeler code: 63868
Product ID: 63868-959_28cd0b68-0d27-bc7b-e063-6294a90a53a1
Type: HUMAN OTC DRUG
Nonproprietary name: Pramoxine hydrochloride, menthol
Dosage form: CREAM
Route: TOPICAL
Labeler: Chain Drug Marketing Association
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-12-07
Substance: MENTHOL; PRAMOXINE HYDROCHLORIDE
Active strength: 1; 1 g/100g; g/100g
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: QC Medicated anti itch
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	1 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
L7T10EIP3A	Internal UNII lookup
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1116155	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
b5e41e3a-81df-3a63-e053-2a95a90a5839	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	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
63868-959-01	QC Medicated anti itch	1 in 1 CARTON	CREAM	1		2
63868-959-01	QC Medicated anti itch	28 g in 1 TUBE	CREAM	28		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-959-01	GM - Gram	63868-959	a2292b26-9014-4510-a2a5-42f34bab2bfc	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-959	QC MEDICATED ANTI ITCH (PRAMOXINE HYDROCHLORIDE, MENTHOL) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	2	Current NDC, Legacy NDC, 2 package rows	20241210_b5e41e3a-81df-3a63-e053-2a95a90a5839.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 114 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medicaine Sting and Bite	BENZOCAINE	James Alexander Corporation	753e6cbe-31e0-4017-93d0-8b4bf5972f37	2024-12-09	Warnings	Exact identifier application number: M017
AUVON Pain Relief Roll-on	MENTHOL	SHENZHEN YUWEN E-COMMERCE CO., LTD.	df239c4d-af6a-41ca-baed-d0788782ce9f	2024-12-08	Warnings	Exact identifier application number: M017
AUVON Pain Relief Roll-on	LIDOCAINE	SHENZHEN YUWEN E-COMMERCE CO., LTD.	8b30f623-6077-4f2e-8fa4-ce4a298953b5	2024-12-08	Warnings	Exact identifier application number: M017
QC Medicated anti itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	Chain Drug Marketing Association	b5e41e3a-81df-3a63-e053-2a95a90a5839	2024-12-08	Warnings	Exact identifier application number: M017 ndc (product): 63868-959
QC Lidocaine Maximum Strength	LIDOCAINE HCL	Chain Drug Marketing Association	b5e1b1ab-8a95-2d2d-e053-2995a90aea53	2024-12-08	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	Alexso, Inc	433da27d-04fb-481a-bbb0-874bb72c806a	2024-12-06	Warnings	Exact identifier application number: M017
POMG PAIN RELIEF BODY	LIDOCAINE	POMG LLC	28d7ac46-b27f-43bb-e063-6294a90a93ed	2024-12-06	Warnings	Exact identifier application number: M017
Capsaicin 0.1 Percent	CAPSAICIN	Alexso, Inc	0090ca38-6433-45c4-9453-edf2788c14c6	2024-12-06	Warnings	Exact identifier application number: M017
Signature Care Menthol	MENTHOL 4%	Safeway	27d3cb47-a6c7-5b7a-e063-6394a90a056f	2024-12-05	Warnings	Exact identifier application number: M017
ITCH X	BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE	BF ASCHER AND CO INC	03c16d33-8f59-0184-e054-00144ff8d46c	2024-12-05	Warnings	Exact identifier application number: M017
PO First Aid Series BURN	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	f1c349a8-216d-4233-922e-c95329a33d1e	2024-12-05	Warnings	Exact identifier application number: M017
Post Treatment Balm	HYDROCORTISONE	Allure Labs Inc.	faa803e6-453c-4d86-85dd-5a5dcdd72d02	2024-12-05	Warnings	Exact identifier application number: M017
CBD Pain Relief Cream	TROLAMINE SALICYLATE	Allure Labs	b6b3102a-4154-2da2-e053-2995a90ae99f	2024-12-05	Warnings	Exact identifier application number: M017
CVS Health Pain Relieving	CAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATE	Natural Essentials, Inc.	f7198485-3d68-41d2-b9b9-f932a0649310	2024-12-04	Warnings	Exact identifier application number: M017
Salonpas LIDOCAINE PLUS	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	Hisamitsu America, Inc.	364924d3-fac3-4f4e-9b40-decd4ec48245	2024-12-03	Warnings	Exact identifier application number: M017
Bite and Itch	DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE	Weeks & Leo Co., Inc.	0a4d471b-c3f3-0a6a-e063-6394a90ad57b	2024-12-03	Warnings	Exact identifier application number: M017
Menthol	AMISH ORIGINS MEDICATED	Amish Origins LLC	547abe39-3af3-4d70-99dd-caf8d67feda2	2024-12-03	Warnings	Exact identifier application number: M017
Meijer Small Cold-Hot Medicated Patches	MENTHOL	Meijer Distribution Inc	be6012d6-2062-45ba-8fc4-abf14cff5845	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	acdd5622-a9a7-4cc3-877e-57efea23303f	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff5	2024-12-03	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1116155	menthol 1 % / pramoxine HCl 1 % Topical Cream	PSN	b5e41e3a-81df-3a63-e053-2a95a90a5839	2
1116155	menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream	SCD	b5e41e3a-81df-3a63-e053-2a95a90a5839	2
1116155	menthol 1 % / pramoxine hydrochloride 1 % Topical Cream	SY	b5e41e3a-81df-3a63-e053-2a95a90a5839	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-959-01	63868095901	1 TUBE in 1 CARTON (63868-959-01) / 28 g in 1 TUBE	1 tube	2020-12-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
QC Medicated Anti Itch Cream	Chain Drug Marketing Association \| Weeks & Leo Co., Inc. \| WEEKS & LEO COMPANY, INC.	2024-12-08	HUMAN OTC DRUG LABEL	2