FDA.reportPublic FDA data

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
IngredientStrength
PRAMOXINE HYDROCHLORIDE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1246075Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
419fa45b-992b-676e-e063-6394a90add81Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82800-200-01Prequel Anti-Itch Solution Medicated Calming400 g in 1 TUBELOTION4003

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 60 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sohm Pain AwayMENTHOL, CAMPHORSOHM, Inc86632acf-80ae-48d7-a0bb-7ec980326bae2025-11-25WarningsExact identifier
application number: M017
HealthWise Lidocaine Pain ReliefLIDOCAINE 4%Veridian Healthcare6f2332c0-e078-40a8-9564-f47d21bc491b2025-11-25WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLC44779065-5f57-8f01-e063-6394a90a3f8e2025-11-25WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLC44786cb6-176e-cc6e-e063-6394a90a54ad2025-11-25WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFVALU MERCHANDISERS, CO3e9c0f5b-cb76-475b-9a2b-39afa1eeb9ff2025-11-24WarningsExact identifier
application number: M017
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDERVALU MERCHANDISERS, CO89a5c4bb-442f-d3f0-e053-2a95a90a51bd2025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d11ab8e-d3ea-c7ef-e063-6294a90ae0a32025-11-24WarningsExact identifier
application number: M017
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d113dec-8832-d984-e063-6394a90ae7b32025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d12f03f-dd8b-0be5-e063-6294a90a43db2025-11-24WarningsExact identifier
application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d129641-eaea-c3ee-e063-6394a90aa58f2025-11-24WarningsExact identifier
application number: M017
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d1059cc-1b0b-4e7b-e063-6294a90a56ea2025-11-24WarningsExact identifier
application number: M017
GuruNanda Pain ReliefMENTHOL AND CAMPHORGURUNANDA, LLC3ca78342-cc6d-5f6b-e063-6294a90a3f1c2025-11-24WarningsExact identifier
application number: M017
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d118256-90ee-28ef-e063-6394a90a21e82025-11-24WarningsExact identifier
application number: M017
health beyondHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.bdcd5b01-f5e2-4519-bf4d-25e3cc7e67af2025-11-23WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine Patches 3 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4429fea8-46f8-8f7f-e063-6394a90a34b42025-11-22WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine Patches 2 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442a926b-d7c1-4e35-e063-6394a90ad9482025-11-22WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine Patches 1 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442aae32-4ac6-5dd6-e063-6294a90aad022025-11-22WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine Patches 1-3 Step21MG NICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442ae0fa-a1ed-7901-e063-6294a90ab7172025-11-22WarningsExact identifier
application number: M017
IceQuake Lidocaine AnalgesicLIDOCAINE HYDROCHLORIDEDextrum Laboratories, Inc441daa6f-f273-ac09-e063-6394a90a252c2025-11-21WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246075pramoxine HCl 1 % Topical LotionPSN419fa45b-992b-676e-e063-6394a90add813
1246075pramoxine hydrochloride 10 MG/ML Topical LotionSCD419fa45b-992b-676e-e063-6394a90add813
1246075pramoxine hydrochloride 1 % Topical LotionSY419fa45b-992b-676e-e063-6394a90add813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82800-200-0182800020001400 g in 1 TUBE (82800-200-01) 400 g2025-10-20NoNoCurrent