Caladryl
- Product NDC
- 0187-5465
- 11-digit product format
- 001875465
- Labeler code
- 0187
- Product ID
- 0187-5465_24add3ce-a1f0-0b6a-e063-6394a90a77c2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Bausch Health US, LLC
- Application
- M014
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-08-16
- Substance
- FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
- Active strength
- 1.36; 78.65; 10 mg/mL; mg/mL; mg/mL
- 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
- Caladryl
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FERRIC OXIDE RED | 1.36 mg/mL |
| ZINC OXIDE | 78.65 mg/mL |
| PRAMOXINE HYDROCHLORIDE | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1K09F3G675 | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
| 88AYB867L5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 67d4fd42-9fed-4238-9f5a-c9403abbcf20 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0187-5465-06 | Caladryl | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0187-5465-06 | ML - Milliliter | 0187-5465 | d7d2d28a-6ac7-4ac3-9b48-8cb69f309c73 | 1 | 2015-05-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Best Choice Earwax Removal Drops | CARBAMIDE PEROXIDE | Valu Merchandisers Company | 3ae6255f-f494-412b-af76-3579de08ed23 | 2025-02-28 | Warnings | M014 |
| Equaline Earwax Removal Drops | CARBAMIDE PEROXIDE | United Natural Foods | d853567a-ce8d-40a8-be1e-27176802ff64 | 2025-02-28 | Warnings | M014 |
| Family Wellness Earwax Removal Earwax and Bulb | CARBAMIDE PEROXIDE | Family Dollar Services Inc | 26ebf208-4710-4af2-aa2d-b2040b85cf85 | 2025-02-28 | Warnings | M014 |
| FOSTER AND THRIVE EARWAX REMOVAL DROPS | CARBAMIDE PEROXIDE | A-S Medication Solutions | 0a571ae8-237b-447d-b697-02b30692b6b1 | 2025-02-24 | Warnings | M014 |
| Pain Be Gone | MENTHOL | Back to Earth Inc. | f49e718b-ef89-b648-e053-2a95a90a96c8 | 2025-01-29 | Warnings | M014 |
| DEBROX | CARBAMIDE PEROXIDE | Medtech Products Inc. | 43649ba3-75e0-4dcf-9172-23767dbaeda6 | 2025-01-27 | Warnings | M014 |
| HylaTears | EYE DROPS | Hyalogic LLC | 2b5fc4c4-843c-8d3d-e063-6394a90a5a1b | 2025-01-10 | Warnings | M014 |
| BODYOGRAPHYPRO ANTI-BACTERIAL SANITIZING | ETHYL ALCOHOL | Robanda International, Inc. | ebec43d4-4676-40f9-b989-5381f4a737c8 | 2025-01-08 | Warnings | M014 |
| Dr. Talbots | ETHYL ALCOHOL | Talbots Pharmaceuticals Family Products, LLC. | a6a94205-a9ff-7709-e053-2995a90a066b | 2025-01-08 | Warnings | M014 |
| Foster and Thrive Earwax Removal Kit Ear wax drops | CARBAMIDE PEROXIDE | Mckesson Corp. Via Strategic Sourcing Services | c9bd4c1f-b3b8-4bdc-b529-3a98b657e628 | 2024-12-31 | Warnings | M014 |
| Foster and Thrive Earwax Removal Drops | CARBAMIDE PEROXIDE | Mckesson Corp. Via Strategic Sourcing Services | 6180835c-d7a7-4bf7-95cb-0fd3c8140253 | 2024-12-31 | Warnings | M014 |
| OIDO SANA | ISOPROPYL ALCOHOL | ProMex LLC | 71e84695-49e8-459f-ac5e-118b5235fe06 | 2024-12-18 | Warnings | M014 |
| ERO Ear Wax Removal Kit | CARBAMIDE PEROXIDE 6.5% | Randob Labs | fbf8a6f2-531d-5047-e053-6294a90aaa01 | 2024-12-15 | Warnings | M014 |
| Harris Teeter Earwax Removal Drops | CARBAMIDE PEROXIDE 6.5% | Harris Teeter LLC | dda4c4bf-425e-4fff-e053-2a95a90a51bc | 2024-12-15 | Warnings | M014 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Mazza Healthcare, LLC | ee83ba9f-ac65-48b7-9f84-5be6fec9a909 | 2024-11-21 | Warnings | M014 |
| Ear Wax Removal Drops Up and Up | CARBAMIDE PEROXIDE - 6.5% | Target Corporation | 829ece50-1f26-4f69-b000-010a34d4cd54 | 2024-11-21 | Warnings | M014 |
| Walgreens Ear Wax Remover | CARBAMIDE PEROXIDE 6.5% | Walgreens Company | d3b7362b-2826-4b86-bfa3-ef302dc79143 | 2024-11-20 | Warnings | M014 |
| CLEARCANAL EAR WAX SOFTERNER DROPS | CARBAMIDE PEROXIDE | A-S Medication Solutions | ac3d57a4-08d5-45f1-be84-f68eef9d1398 | 2024-11-04 | Warnings | M014 |
| Caladryl Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Bausch Health US, LLC | fca6f08b-7fa0-4ae6-bce3-61f3bcae4332 | 2024-10-17 | Warnings | M014 |
| Caladryl | FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE | Bausch Health US, LLC | 67d4fd42-9fed-4238-9f5a-c9403abbcf20 | 2024-10-17 | Warnings | M014 0187-5465 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1234533 | Caladryl 8 % / 1 % Topical Lotion | PSN | 67d4fd42-9fed-4238-9f5a-c9403abbcf20 | 6 |
| 1234532 | calamine 8 % / pramoxine HCl 1 % Topical Lotion | PSN | 67d4fd42-9fed-4238-9f5a-c9403abbcf20 | 6 |
| 1234533 | calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Caladryl] | SBD | 67d4fd42-9fed-4238-9f5a-c9403abbcf20 | 6 |
| 1234532 | calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion | SCD | 67d4fd42-9fed-4238-9f5a-c9403abbcf20 | 6 |
| 1234533 | Caladryl (calamine 8 % / pramoxine hydrochloride 1 % ) Topical Lotion | SY | 67d4fd42-9fed-4238-9f5a-c9403abbcf20 | 6 |
| 1234532 | calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion | SY | 67d4fd42-9fed-4238-9f5a-c9403abbcf20 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0187-5465-06 | 00187546506 | 177 mL in 1 BOTTLE, PLASTIC (0187-5465-06) | 177 ml | 2013-08-16 | 0000-00-00 | No | No | Current |