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 107 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DCH Labs Cool and Heat Roll-On	MENTHOL 16%	Derma Care Research Labs, LLC	d35d7720-44ce-3624-e053-2995a90a7fb4	2024-12-19	Warnings	Exact identifier application number: M017
Dr Goldsons Pain	MENTHOL 8%, METHYL SALICYLATE 30%	Derma Care Research Labs, LLC	fb34b0d3-ccc0-305e-e053-6394a90a231d	2024-12-19	Warnings	Exact identifier application number: M017
Warrior Pain Relieving	CAMPHOR 4%, MENTHOL 10%, METHYL SALICYLATE 30%	Derma Care Research Labs, LLC	dd06af3c-5452-9759-e053-2a95a90afc21	2024-12-19	Warnings	Exact identifier application number: M017
Warrior Burn Relief Aloe Maximum Strength	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	ec6efa4b-dcbe-1c2b-e053-2995a90ae043	2024-12-19	Warnings	Exact identifier application number: M017
DCH Arthritis Relief	TROLAMIN SALICYLATE 10%	Derma Care Research Labs, LLC	ff31e515-5780-b77d-e053-6394a90af6b9	2024-12-19	Warnings	Exact identifier application number: M017
DCH Pain Relief	LIDOCAINE 4%	Derma Care Research Labs, LLC	00efda74-d434-04be-e063-6294a90a6d98	2024-12-19	Warnings	Exact identifier application number: M017
Dollar General Cold Therapy Pain Relief	MENTHOL 5%	Dolgencorp, LLC	ff3284d1-e73c-93bf-e053-6294a90aaf4e	2024-12-19	Warnings	Exact identifier application number: M017
Dollar General Pain Relieving Patch with Lidocaine	LIDOCAINE	DOLGENCORP, LLC	55828cd1-3a1e-48ac-bb01-4c50b96d09a2	2024-12-19	Warnings	Exact identifier application number: M017
DCH Nerve Pain Relief	LIDOCAINE 4%, MENTHOL 1%	Derma Care Research Labs, LLC	00db480a-e510-a64d-e063-6394a90a4695	2024-12-19	Warnings	Exact identifier application number: M017
Pain, Burn, and Itch Relief	BENZOCAINE 20%, MENTHOL 0.5%	Derma Care Research Labs, LLC	fd9fe09f-3ae9-c5f5-e053-6394a90ad691	2024-12-19	Warnings	Exact identifier application number: M017
DCH Cooling Pain Relief	MENTHOL 4%	Derma Care Research Labs, LLC	00ed3175-c3ba-6545-e063-6394a90acfd1	2024-12-19	Warnings	Exact identifier application number: M017
DCH Pain Relief	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	00dd70f3-ecc3-33ba-e063-6294a90a4f32	2024-12-19	Warnings	Exact identifier application number: M017
Walgreens Kinesiology Pain Relief	LIDOCAINE, MENTHOL	Walgreen Co.	0fdbb310-8e65-4e0c-b413-a093964324a2	2024-12-19	Warnings	Exact identifier application number: M017
Signature Care Medicated Cold and Hot Patch	MENTHOL	Safeway	0335f1b3-5c8a-67b8-e063-6294a90a9847	2024-12-19	Warnings	Exact identifier application number: M017
HealthWise 4% Lidocaine Cream	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	0fb2af30-7f2d-c7c4-e063-6294a90a37f7	2024-12-19	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain Relief	LIDOCAINE HCL	CVS Pharmacy	445b0778-7266-4e72-97cc-e9e0d0066b61	2024-12-18	Warnings	Exact identifier application number: M017
Dr. Scholls Blister Pain Relief Complete	LIDOCAINE	Scholl's Wellness Company LLC	26e3a678-b28f-588b-e063-6394a90ac025	2024-12-18	Warnings	Exact identifier application number: M017
Dr. Scholls Blister Pain Relief Complete	LIDOCAINE	Scholl's Wellness Company LLC	d860b339-48a0-405c-a67d-f7e7a31f6351	2024-12-18	Warnings	Exact identifier application number: M017
TheraCare Pain Relief Lidocaine	LIDOCAINE	Veridian Healthcare	cea6cdab-28a5-5bd0-e053-2a95a90a1295	2024-12-18	Warnings	Exact identifier application number: M017
TheraCare Pain Relief Medicated	LIDOCAINE AND MENTHOL	Veridian Healthcare	0d092461-85fe-acf6-e063-6294a90a5aae	2024-12-18	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