Prequel Anti-Itch Solution Medicated Calming

Product NDC: 82800-200
11-digit product format: 828000200
Labeler code: 82800
Product ID: 82800-200_4c9bac93-a769-93fb-e063-6294a90ab661
Type: HUMAN OTC DRUG
Nonproprietary name: Medicated Calming Lotion
Dosage form: LOTION
Route: TOPICAL
Labeler: The Center Brands, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-10-20
Substance: PRAMOXINE HYDROCHLORIDE
Active strength: 1 g/100g
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: Prequel Anti-Itch Solution Medicated Calming
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
1246075	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
419fa45b-992b-676e-e063-6394a90add81	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
82800-200-01	Prequel Anti-Itch Solution Medicated Calming	400 g in 1 TUBE	LOTION	400		3

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 110 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ultra Strength Muscle Rub	CAMPHOR, MENTHOL, METHYL SALICYLATE	The Mentholatum Company	32b64985-0e2f-49ee-9840-946d7279fee7	2024-12-17	Warnings	Exact identifier application number: M017
CVS Health Cold and Hot Pain Relieving Extra Strength	MENTHOL, METHYL SALICYLATE	CVS Pharmacy	1ca1a631-cb2c-46cd-bd41-05469b08d208	2024-12-17	Warnings	Exact identifier application number: M017
Mentholatum Pain Relieving	MENTHOL, METHYL SALICYLATE	The Mentholatum Company	0056b952-9870-485a-9f35-f985472875a9	2024-12-17	Warnings	Exact identifier application number: M017
Mentholatum Lidocaine Heat	LIDOCAINE HCL	The Mentholatum Company	cc2ef25a-b569-4d48-a666-899f710b4b34	2024-12-17	Warnings	Exact identifier application number: M017
Rite Aid Muscle Rub Ultra Strength	CAMPHOR, MENTHOL, METHYL SALICYLATE	Rite Aid Corporation	039fff40-b5ba-42cb-932c-8a70ca92759d	2024-12-17	Warnings	Exact identifier application number: M017
Signature Care Cold and Hot Medicated	MENTHOL	Safeway	88f59f95-0a7c-458c-949c-0dff16ad94e4	2024-12-17	Warnings	Exact identifier application number: M017
Equate Cool and Heat	MENTHOL, METHYL SALICYLATE	Wal-Mart Stores Inc	c5ab2426-eeca-4ba4-9f00-7790d2176471	2024-12-17	Warnings	Exact identifier application number: M017
CVS Health Muscle Rub Ultra Strength	CAMPHOR, MENTHOL, METHYL SALICYLATE	CVS Pharmacy	4fc0d6bb-efa7-40cf-a6d5-e0feaa93c80a	2024-12-17	Warnings	Exact identifier application number: M017
DG Health Maximum Strength Pain Relieving Cleansing	BENZALKONIUM CL, LIDOCAINE HCL	Dollar General Corporation	64f69315-77a3-49dc-940d-efd7a29c6645	2024-12-17	Warnings	Exact identifier application number: M017
Chiggerex	BENZOCAINE	RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH	5e5d84ab-f57f-448d-a4c1-ced38890eec2	2024-12-17	Warnings	Exact identifier application number: M017
DerMend Moisturizing Anti-Itch	PRAMOXINE HYDROCHLORIDE	Ferndale Laboratories, Inc.	14c7fb1c-a310-4b12-ab2e-7f1c0801995c	2024-12-17	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	Geri-Care Pharmaceuticals, Corp	fd67566a-1076-019d-e053-6394a90a415c	2024-12-17	Warnings	Exact identifier application number: M017
Extra Strength	MENTHOL AND METHYL SALICYLATE	NATURES FORMULAE HEALTH PRODUCTS LTD.	d919b50a-5de2-1830-e053-2a95a90ab88d	2024-12-17	Warnings	Exact identifier application number: M017
Cold and Heat Lidocaine Patch Plus Menthol	LIDOCAINE, MENTHOL	Walgreen Company	1f262473-3f3c-4f3f-b507-590d06ff69a9	2024-12-17	Warnings	Exact identifier application number: M017
Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Walgreen Company	db8cf218-7544-4871-b1c3-a50a3d3e59f1	2024-12-17	Warnings	Exact identifier application number: M017
Albertsons Pain Relief Patch	LIDOCAINE	Safeway	dc2823bb-8586-daca-e053-2995a90a2af0	2024-12-17	Warnings	Exact identifier application number: M017
CAPSAICIN HEAT PATCHES BACK AND LARGE AREAS	CAPSAICIN	Walgreen Company	e77167ab-6cb8-4d5b-838c-b0acc05e3889	2024-12-17	Warnings	Exact identifier application number: M017
Hot and Cold Medicated Patch	MENTHOL	Walgreen Company	d9fc133d-ebaa-48f1-a6f9-62453970012b	2024-12-17	Warnings	Exact identifier application number: M017
PAIN RELIEF PATCHES	LIDOCAINE	Walgreen Company	204b96bc-af4e-4842-8b57-7b416feb4dd9	2024-12-17	Warnings	Exact identifier application number: M017
Lidocaine Dry	LIDOCAINE	CVS	bb7955fe-5113-1662-e053-2a95a90a85a1	2024-12-16	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
1246075	pramoxine HCl 1 % Topical Lotion	PSN	419fa45b-992b-676e-e063-6394a90add81	3
1246075	pramoxine hydrochloride 10 MG/ML Topical Lotion	SCD	419fa45b-992b-676e-e063-6394a90add81	3
1246075	pramoxine hydrochloride 1 % Topical Lotion	SY	419fa45b-992b-676e-e063-6394a90add81	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82800-200-01	82800020001	400 g in 1 TUBE (82800-200-01)	400 g	2025-10-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prequel Anti-Itch Solution Medicated Calming Lotion	The Center Brands, LLC	2026-03-09	HUMAN OTC DRUG LABEL	3