Calamine
- Product NDC
- 76162-336
- 11-digit product format
- 761620336
- Labeler code
- 76162
- Product ID
- 76162-336_4ab90806-7257-8b97-e063-6294a90a71c3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine, Pramoxine HCl
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Topco Associates LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2009-05-21
- 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 |
|---|---|
| 15d1ae3f-509c-4e6b-8f0c-cf9265680358 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | 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 |
|---|---|---|---|---|---|---|
| 76162-336-30 | Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 7 |
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 |
|---|---|---|---|---|---|---|
| Petroleum | WHITE PETROLATUM | Harris Teeter | de380df6-cc6e-4b2a-98de-fc08eeb6e8ea | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Hy-Vee, Inc. | 45867f42-9562-c111-e063-6394a90adb70 | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | Lidl US, LLC | c82f236d-c27f-458c-bcd8-19877d09e9a3 | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | Lidl US, LLC | 5e83811f-773f-43e7-bab8-f9e558fb0e00 | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Major Pharmaceuticals | c25be68d-834a-4959-8d47-01ec789406ba | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | Major Pharmaceuticals | 0e7e11c5-a1f8-43c4-b8a6-211491052404 | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | d76e116f-4b22-4633-8487-17ad3b5778c7 | 2026-02-04 | Warnings | M016 |
| Comforts Petroleum Jelly | WHITE PETROLATUM | KROGER | 3feb3638-1cdc-62d4-e063-6294a90a1d89 | 2026-02-03 | Warnings | M016 |
| Daily Moisturizing | DIMETHICONE | CVS Pharmacy, Inc. | edc20df4-561e-486f-b9f1-900672a0f2a4 | 2026-02-03 | Warnings, Adverse reactions | M016 |
| Colloidal oatmeal | COLLOIDAL OATMEAL | CVS Pharmacy, Inc. | a153842c-d9ce-4658-912b-362a6f20b0aa | 2026-02-03 | Warnings, Adverse reactions | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | Demoulas Super Markets, Inc | 702215f0-4cfd-4a23-b47a-da691c136634 | 2026-02-03 | Warnings, Adverse reactions | M016 |
| Neurexa | COLLOIDAL OATMEAL | METHODIQ INC. | 494d7915-acad-260e-e063-6394a90a182c | 2026-02-03 | Warnings | M016 |
| Thera Plus Vitamin A and D Cream | DIMETHICONE, ZINC OXIDE | FOURSTAR GROUP USA, INC. | 36f09fa4-a3b8-4104-9745-ee60aa493b06 | 2026-02-02 | Warnings | M016 |
| Vitamin A D | LANOLIN, PETROLATUM | Kroger Co. | b4aa9b58-d95e-4dac-9a34-213482e8ca34 | 2026-02-02 | Warnings, Adverse reactions | M016 |
| Nail Nourishing Pen | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 49e45462-a05f-d370-e063-6394a90a1e0f | 2026-02-02 | Warnings | M016 |
| Barrier Repair Cream | CREAM | Steel City Health Private Limited | 4842f653-7137-eca4-e063-6394a90a8c55 | 2026-01-31 | Warnings | M016 |
| Cracked Heel Repair Balm | DIMETHICONE | Delta Brands Inc. | 42b7c9f8-0557-8e33-e063-6394a90a5919 | 2026-01-30 | Warnings | M016 |
| Readybath TPC Total Perineal Care | DIMETHICONE | Medline Industries, Inc. | 43a3f0f7-f76f-434d-a21f-7eaa3638913d | 2026-01-30 | Warnings | M016 |
| Lanolin, Petrolatum | LANOLIN, PETROLATUM | Rite Aid Corporation | 1b6d7cdf-e7bc-4fd4-939c-5eb0eaa1744d | 2026-01-30 | Warnings, Adverse reactions | M016 |
| Zinc Oxide | ZINC OXIDE | Rite Aid Corporation | 3af9f0e5-0d79-4178-b29e-3b60735bf4ce | 2026-01-30 | Warnings, Adverse reactions | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1234532 | calamine 8 % / pramoxine HCl 1 % Topical Lotion | PSN | 15d1ae3f-509c-4e6b-8f0c-cf9265680358 | 7 |
| 1234532 | calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion | SCD | 15d1ae3f-509c-4e6b-8f0c-cf9265680358 | 7 |
| 1234532 | calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion | SY | 15d1ae3f-509c-4e6b-8f0c-cf9265680358 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 76162-336-30 | 76162033630 | 177 mL in 1 BOTTLE, PLASTIC (76162-336-30) | 177 ml | 2009-05-21 | 0000-00-00 | No | No | Current |