FDA.reportPublic FDA data

Rite Aid Cala Itch Relief

Product NDC
11822-3101
11-digit product format
118223101
Labeler code
11822
Product ID
11822-3101_2956dcd8-2fd4-cea7-e063-6294a90aee82
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine HCl 1%, Zinc Acetate 0.1%
Dosage form
SPRAY
Route
TOPICAL
Labeler
Rite Aid
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-31
Substance
PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active strength
1; .1 g/100g; g/100g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
Rite Aid Cala Itch Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE1 g/100g
ZINC ACETATE.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup
FM5526K07AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1294033Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e29a9d59-4c7c-81aa-e053-2995a90a7056Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
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
11822-3101-3Rite Aid Cala Itch Relief85 g in 1 CANSPRAY852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3101RITE AID CALA ITCH RELIEF (PRAMOXINE HCL 1%, ZINC ACETATE 0.1%) SPRAY [RITE AID]2Current NDC, Legacy NDC, 1 package rows20241217_e29a9d59-4c7c-81aa-e053-2995a90a7056.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 104 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTI ITCHHYDROCORTISONESafeway0bfa1653-76b7-48ed-a896-a0b5fc3bd7942025-01-08WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINEEpic Medical Supply Corp259fbfe4-d67c-ea1e-e063-6294a90a0fb02025-01-07WarningsExact identifier
application number: M017
Sinsin MulpasCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.22ea8a51-fdee-4650-abf8-f996268c93032025-01-07WarningsExact identifier
application number: M017
SINSINPAP COOLLEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUSSinsin Pharmaceutical Co., Ltd.9d47855f-ccb5-4557-a31a-a2b336fa98062025-01-07WarningsExact identifier
application number: M017
Burn JelLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesff621b46-2342-41db-994d-851a09796d082025-01-06WarningsExact identifier
application number: M017
Lidocare Arm, Neck, Leg4% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC59a104ee-7034-99c3-e053-2991aa0a164c2025-01-06WarningsExact identifier
application number: M017
Salonpas LIDOCAINE Pain RelievingLIDOCAINEHisamitsu Pharmaceutical Co., Inc.4f3a438c-f378-4d2a-a95c-58e56cf1e7972025-01-06WarningsExact identifier
application number: M017
Lidocare 034% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC416ebf5a-2efb-6d0b-e054-00144ff88e882025-01-06WarningsExact identifier
application number: M017
AVCOO Pain Relief Roll-onMENTHOLADP Health Limitede0bb77b2-45ee-45fa-9659-9c7d99bb20dc2025-01-05WarningsExact identifier
application number: M017
health and beyond BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b6bb3ed-50fb-40c4-acb6-ae3f160315312025-01-05WarningsExact identifier
application number: M017
glo SKIN BEAUTY Remedy GelGLO SKIN BEAUTY REMEDY GELHayden Caleel LLCaa47ff08-07b3-4fd1-bae5-420e4b928f062025-01-05WarningsExact identifier
application number: M017
Capsaicin 0.025% CreamCAPSAICIN 0.025%Puretek Corporation28f00df0-c416-f17b-e063-6294a90a55702025-01-02WarningsExact identifier
application number: M017
AVON HeXashield Pain Relief for Muscle, Back and Joint CreamCAMPHOR, MENTHOL, METHYL SALICYLATETai Guk Pharm. Co., Ltd.8f29ffd7-48b9-109f-e053-2995a90ab2152025-01-01WarningsExact identifier
application number: M017
AVON HeXashield Arthritis Pain Relief Cream CapsaisinCAPSAISINTai Guk Pharm. Co., Ltd.8f286a9d-8765-21b3-e053-2a95a90ae43a2025-01-01WarningsExact identifier
application number: M017
AVON HeXashield Anti Itch Cream with Healing AloeHYDROCORTISONETai Guk Pharm. Co., Ltd.8f2aa11d-d794-6f3e-e053-2995a90a1d9d2025-01-01WarningsExact identifier
application number: M017
HeXashield Anti Itch Cream with Healing AloeHYDROCORTISONETai Guk Pharm. Co., Ltd.b9d033f3-4d12-a2c8-e053-2995a90ac7f12025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Pain Relief with MentholMENTHOLGreen Compass, Inc.0a0c212e-ae5d-8505-e063-6394a90af6222025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEGreen Compass, Inc.0a0b688e-50f1-3eb1-e063-6394a90a7efa2025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Topical PainCAMPHOR, MENTHOL, METHYL SALICYLATEGreen Compass, Inc.8cb80362-5d24-1ee3-e053-2a95a90afcdf2025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Roll-On Pain ReliefMENTHOLGreen Compass, Inc.b5916aa2-428c-5637-e053-2995a90a08b02025-01-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1294033pramoxine HCl 1 % / zinc acetate 0.1 % Topical SprayPSNe29a9d59-4c7c-81aa-e053-2995a90a70562
1294033pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical SpraySCDe29a9d59-4c7c-81aa-e053-2995a90a70562
1294033pramoxine HCl 1 % / zinc acetate 0.1 % Topical SpraySYe29a9d59-4c7c-81aa-e053-2995a90a70562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-3101-31182231010385 g in 1 CAN (11822-3101-3) 85 g2021-03-310000-00-00NoNoCurrent