Calamine
- Product NDC
- 83324-053
- 11-digit product format
- 833240053
- Labeler code
- 83324
- Product ID
- 83324-053_4bcf72e3-68ba-8e7d-e063-6294a90a7536
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine, Pramoxine HCl
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Chain Drug Marketing Association
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-02-26
- Substance
- FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE
- Active strength
- 80; 10 mg/mL; mg/mL
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FERRIC OXIDE RED | 80 mg/mL |
| PRAMOXINE HYDROCHLORIDE | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1K09F3G675 | Internal UNII lookup |
| 88AYB867L5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1234532 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6c848b98-f01c-40f2-a9aa-2af76cb370c8 | 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 |
|---|---|---|---|---|---|---|
| 83324-053-06 | Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83324-053-06 | ML - Milliliter | 83324-053 | 533b1be6-53af-49e3-a19c-e445287293c6 | 1 | 2025-05-14 |
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 |
|---|---|---|---|---|---|---|
| Aveeno Baby Eczema Therapy Moisturizing | OATMEAL | Kenvue Brands LLC | 21d2c0a0-70c3-7fd3-e063-6394a90a46d4 | 2025-04-18 | Warnings | M016 |
| Secura Extra Protective | ZINC OXIDE | Smith & Nephew Medical Ltd | 499a1944-1682-4798-9058-3748a5eaa420 | 2025-04-17 | Warnings | M016 |
| Firming Care Gel | FIRMING CARE GEL | Guangzhou Jiaan Cosmetics Co.,Ltd. | 32cb8a71-81cd-cdbd-e063-6394a90ac07f | 2025-04-15 | Warnings | M016 |
| Baby Mantra Diaper Cream | ZINC OXIDE 10% | Renu Laboratories, LLC | 0427bbc9-f4c0-0eb6-e063-6294a90a7199 | 2025-04-14 | Warnings | M016 |
| Witch Hazel | WITCH HAZEL | TOP CARE (Topco Associates LLC) | 23b592f7-3af3-45ef-897a-fe33ab518b6d | 2025-04-14 | Warnings | M016 |
| Witch Hazel | WITCH HAZEL | Strategic Sourcing Services LLC | ef3408db-de98-4a43-9215-f80fed14815c | 2025-04-14 | Warnings | M016 |
| Petroleum Jelly | PETROLATUM | Walgreens | 69bdd508-7c33-42c5-9a08-e56cf3eaebf3 | 2025-04-11 | Warnings | M016 |
| 4% 10gTATTOO Numb Cream | 4% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 322daa32-a74e-1fee-e063-6294a90a37aa | 2025-04-07 | Warnings | M016 |
| Aluroderm Scar | ALLANTOIN | Asclemed USA, Inc. | 60656ca1-5218-4595-854e-19f1061def1e | 2025-04-01 | Warnings | M016 |
| Dr. Maxs Diaper | ZINC OXIDE | Dr. Maxs LLC | 31bfa962-5e3b-c5d2-e063-6294a90ac177 | 2025-04-01 | Warnings | M016 |
| Vaseline | BABY HEALING JELLY | Conopco Inc. d/b/a Unilever | bca3176f-86fe-5969-e053-2995a90a2419 | 2025-03-31 | Warnings | M016 |
| 4% TATTOO Numb Cream | 4% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 31646815-f591-c560-e063-6294a90ad11a | 2025-03-28 | Warnings | M016 |
| Face Saver Gel | SKIN PROTECTANT GEL | Neat Feat Products Limited | 31563dd7-9f58-80f6-e063-6294a90a5571 | 2025-03-27 | Warnings | M016 |
| Porphose | COLLOIDAL OATMEAL TOPICAL SPRAY | Porphose | 315951e0-899f-c968-e063-6294a90abe61 | 2025-03-27 | Warnings | M016 |
| Petroleum Jelly | WHITE PETROLATUM JELLY | WALGREENS | 1fc9eecd-fd25-827c-e063-6394a90a26a5 | 2025-03-26 | Warnings | M016 |
| Cocoa Butter Petroleum Jelly | WHITE PETROLATUM JELLY | WALGREENS | 1fcc9626-6058-e9b3-e063-6394a90ab525 | 2025-03-26 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 313b08e2-d764-96da-e063-6294a90ab705 | 2025-03-25 | Warnings | M016 |
| Eczema Cream | ECZEMA CREAM | Kyte Baby LLC | 30c943aa-d9dc-5c16-e063-6294a90a3c58 | 2025-03-20 | Warnings | M016 |
| Koala Kubs Diaper Rash Cream | DIAPER RASH CREAM | Melaleuca, Inc. | c6b3b0dd-22a8-16f7-e053-2a95a90a51ea | 2025-03-20 | Warnings | M016 |
| Gold Bond Eczema Relief Medicated Skin Protectant Cream | COLLOIDAL OATMEAL | Chattem, Inc. | 2b6b8342-878d-4588-8b24-6746d35d319d | 2025-03-19 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1234532 | calamine 8 % / pramoxine HCl 1 % Topical Lotion | PSN | 6c848b98-f01c-40f2-a9aa-2af76cb370c8 | 3 |
| 1234532 | calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion | SCD | 6c848b98-f01c-40f2-a9aa-2af76cb370c8 | 3 |
| 1234532 | calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion | SY | 6c848b98-f01c-40f2-a9aa-2af76cb370c8 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83324-053-06 | 83324005306 | 177 mL in 1 BOTTLE, PLASTIC (83324-053-06) | 177 ml | 2025-02-26 | No | No | Current |