FDA.reportPublic FDA data

Calamine Plus

Product NDC
30142-429
11-digit product format
301420429
Labeler code
30142
Product ID
30142-429_59f65b2b-3a6d-6e4f-e063-6294a90aac6a
Type
HUMAN OTC DRUG
Nonproprietary name
calamine, pramoxine hydrochloride
Dosage form
SPRAY
Route
TOPICAL
Labeler
Kroger Company
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-16
Substance
ZINC OXIDE; PRAMOXINE HYDROCHLORIDE; FERRIC OXIDE RED
Active strength
79.6; 10; .4 mg/g; mg/g; mg/g
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
Calamine Plus
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE79.6 mg/g
PRAMOXINE HYDROCHLORIDE10 mg/g
FERRIC OXIDE RED.4 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
88AYB867L5Internal UNII lookup
1K09F3G675Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1544717Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
44fdd5a4-3cac-15e5-e063-6294a90adb52Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-429-41Calamine Plus116 g in 1 CANSPRAY1162

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 3 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
application number: M017
ndc (product): 30142-429
Lidocaine Pain ReliefLIDOCAINECardinal Health, 110 dba LEADER025d508b-ec4f-466c-b3e8-ba9b18d07b462026-08-26WarningsExact identifier
application number: M017
Inknows Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.59eb9c12-9e00-0171-e063-6394a90a83422026-08-25WarningsExact identifier
application number: M017
LidomarLIDOMAROncora Pharma, LLC215bfdca-60bf-480b-b02e-902de52fe5e82026-08-25WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAmazon.com Services LLC5f87d7fb-f258-48b0-8b60-1055e22ebd712026-08-25WarningsExact identifier
application number: M017
HEEL PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c7e13f-b9ea-023a-e063-6294a90a79e02026-08-24WarningsExact identifier
application number: M017
KNEE PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c8b33a-7d4f-2c6e-e063-6394a90a79292026-08-24WarningsExact identifier
application number: M017
Bovonte Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5958cc29-c449-56a7-e063-6394a90a960b2026-08-24WarningsExact identifier
application number: M017
HUSTLE BUTTER NUMBINGLIDOCAINE HYDROCHLORIDEH.B.D. D.I.S.T. INC.d7dfb312-6c80-4a2d-b8b2-d9891cb0b74e2026-08-24WarningsExact identifier
application number: M017
JELVOXA NECK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.59a3d60a-26b5-e6a6-e063-6294a90a42bd2026-08-22WarningsExact identifier
application number: M017
JELVOXA DMSOCAMPHOR CAPSAICIN MENTHOLWuhan Ruihengjie Technology Co., Ltd.59a43e2c-d258-34b5-e063-6394a90a09bf2026-08-22WarningsExact identifier
application number: M017
Capsaicin 0.035 PercentCAPSAICINPreferred Pharmaceuticals Inc.0fabc025-4208-45f5-b3c2-543ae3a2df412026-08-21WarningsExact identifier
application number: M017
ClaravieHYDROCORTISONE ACETATEGentell LLC598d224b-d12e-89bf-e063-6394a90a84dc2026-08-21WarningsExact identifier
application number: M017
ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVINGMENTHOL, CAMPHORWorldwide Cosmetics, Inc3b8c2419-7a78-2731-e054-00144ff8d46c2026-08-21WarningsExact identifier
application number: M017
PARCHE FRIOMETHYL SALICYLATE, MENTHOL, AND CAMPHOR PATCHDW SUPPORT LLC5970a6f7-b273-9bb1-e063-6394a90afc792026-08-21WarningsExact identifier
application number: M017
Enokon Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.5976e667-e506-1d11-e063-6394a90a68092026-08-20WarningsExact identifier
application number: M017
MQUPIN TIGER PatchTIGER PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.5977cbb5-94c7-cb24-e063-6294a90a2e072026-08-20WarningsExact identifier
application number: M017
MQUPIN Nicotine PatchesNICOTINE PATCHESZhengzhou Miaoqi Medical Technology Co., Ltd.5978258a-549e-50e6-e063-6394a90a3d862026-08-20WarningsExact identifier
application number: M017
ClaravieCAMPHORGentell LLC5978bdab-5359-be9a-e063-6394a90a5a322026-08-20WarningsExact identifier
application number: M017
Rugby PAIN RELIEF PATCHESLIDOCAINERUGBY LABORATORIESb34e40c8-a257-46cf-9399-f55df9b4102d2026-08-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544717calamine 8 % / pramoxine HCl 1 % Topical SprayPSN44fdd5a4-3cac-15e5-e063-6294a90adb522
1544717calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD44fdd5a4-3cac-15e5-e063-6294a90adb522
1544717calamine 8 % / pramoxine hydrochloride 1 % Topical SpraySY44fdd5a4-3cac-15e5-e063-6294a90adb522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
30142-429-4130142042941116 g in 1 CAN (30142-429-41) 116 g2026-04-16NoNoCurrent