Calamine
- Product NDC
- 79481-0336
- 11-digit product format
- 794810336
- Labeler code
- 79481
- Product ID
- 79481-0336_4b3377fe-fe16-b828-e063-6294a90a9745
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine, Pramoxine HCl
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Meijer, Inc.
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2009-06-17
- 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 |
|---|---|
| 6b369ef2-fd54-4931-a9eb-0fb42834c2ef | 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 |
|---|---|---|---|---|---|---|
| 79481-0336-1 | Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 79481-0336 | CALAMINE (CALAMINE, PRAMOXINE HCL) LOTION [MEIJER DISTRIBUTION, INC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241114_6b369ef2-fd54-4931-a9eb-0fb42834c2ef.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| DawnMist White Petrolatum | WHITE PETROLATUM | Dukal LLC | 598e9d46-6450-af60-e063-6394a90a3a6b | 2026-08-21 | Warnings | M016 |
| MUSTELA Diaper Rash 1 2 3 | ZINC OXIDE | Expanscience Laboratories d/b/a Mustela | 163f388e-849d-4b7e-93c1-9045d77a9ec2 | 2026-08-21 | Warnings | M016 |
| Medline | WHITE PETROLATUM, ZINC OXIDE | Medline Industries, LP | 0073de92-585d-e01a-e063-6394a90a2ec2 | 2026-08-21 | Warnings | M016 |
| Mederma PM | DIMETHICONE | L Perrigo Company | 8c728904-28f4-4333-a9ea-20996fd1b007 | 2026-08-21 | Warnings | M016 |
| Earths Care Hemorrhoid Relief | WITCH HAZEL AND MENTHOL, UNSPECIFIED FORM | DLC Laboratories, Inc. | e860d65b-126d-4d77-8003-9d1381849ab5 | 2026-08-20 | Warnings | M016 |
| ClaraVie | PETROLATUM | Gentell LLC | 596987e4-4205-b911-e063-6294a90aa570 | 2026-08-19 | Warnings | M016 |
| ClaraVie | ZINC OXIDE | Gentell LLC | 596abd98-17d7-2a22-e063-6294a90af57d | 2026-08-19 | Warnings | M016 |
| Claravie Skin Repair Cream | DIMETHICONE | Gentell LLC | 596ae269-172e-aef5-e063-6394a90a4e2a | 2026-08-19 | Warnings | M016 |
| Claravie | LANOLIN | Gentell LLC | 596c1b73-e34d-c97d-e063-6394a90ada1b | 2026-08-19 | Warnings | M016 |
| ClaraVie | MENTHOL, ZINC OXIDE | Gentell LLC | 596c467f-a056-ea78-e063-6394a90a79f2 | 2026-08-19 | Warnings | M016 |
| ClaraVie | LANOLIN | Gentell LLC | 596fe32d-be34-0635-e063-6394a90a2fc0 | 2026-08-19 | Warnings | M016 |
| Medpride | ZINC OXIDE | Shield Line LLC | e2689cae-e347-4c0b-825b-6281a0b7c2f1 | 2026-08-18 | Warnings | M016 |
| Eczema Skin Relief Cream | COLLOIDAL OATMEAL | CVS Health | 98fac854-f7b0-4c6e-888d-1bdc6b9323b9 | 2026-08-17 | Warnings | M016 |
| Zinc Oxide | ZINC OXIDE | ADUSA Distribution, LLC | 5940399c-31e3-6d51-e063-6294a90a8e7c | 2026-08-17 | Warnings, Adverse reactions | M016 |
| Intimate CareGel | HYALURONIC ACID | Guangzhou Yilong Cosmetics.,Ltd | 5918d204-52db-e6d0-e063-6394a90ab78c | 2026-08-14 | Warnings | M016 |
| TENA Proskin protective cream | ZINC OXIDE | Essity HMS North America Inc. | b840377f-a297-4aff-900e-7ea8b7c98717 | 2026-08-13 | Warnings, Adverse reactions | M016 |
| Medline | WHITE PETROLATUM, ZINC OXIDE | Medline Industries, LP | 087d66ff-1a8c-dcb2-e063-6294a90a2f8c | 2026-08-11 | Warnings | M016 |
| Nail Renewal Liquid | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 581f7192-fc17-a706-e063-6394a90a3ffa | 2026-08-11 | Warnings | M016 |
| Intertrigo Relief Cream | GLYCERIN | Shantou South Moon Biotechnology Co., Ltd. | 587220c9-0ae9-3438-e063-6394a90a0a86 | 2026-08-07 | Warnings | M016 |
| Calamine | FERRIC OXIDE RED | The Kroger Co. | 9ddcd6ba-1aed-48f8-a91a-54bd6f0d9308 | 2026-08-06 | Warnings, Adverse reactions | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1234532 | calamine 8 % / pramoxine HCl 1 % Topical Lotion | PSN | 6b369ef2-fd54-4931-a9eb-0fb42834c2ef | 7 |
| 1234532 | calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion | SCD | 6b369ef2-fd54-4931-a9eb-0fb42834c2ef | 7 |
| 1234532 | calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion | SY | 6b369ef2-fd54-4931-a9eb-0fb42834c2ef | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 79481-0336-1 | 79481033601 | 177 mL in 1 BOTTLE, PLASTIC (79481-0336-1) | 177 ml | 2009-06-17 | 0000-00-00 | No | No | Current |