Calamine
- Product NDC
- 11344-136
- 11-digit product format
- 113440136
- Labeler code
- 11344
- Product ID
- 11344-136_5c148e64-6bd1-2028-e063-6294a90a2872
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine, Pramoxind HCl
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Nice-Pak Products, LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-09-08
- 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 |
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 |
|---|---|---|---|---|---|---|
| 11344-136-30 | Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 3 |
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 |
|---|---|---|---|---|---|---|
| Clear Anti-Itch | PRAMOXINE HCL, ZINC ACETATE | Old East Main Co. | 91df1434-bce6-4c6e-beee-cb5ec1cc8fff | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Old East Main Co. | cf916191-1de2-4305-b783-9e074c1ad94b | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Eczema Relief | COLLOIDAL OATMEAL | Old East Main Co. | b2dba027-c295-4a41-8d30-144904e1aa34 | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Baby Eczema Therapy | COLLOIDAL OATMEAL | Old East Main Co. | 9720e2ad-1bcf-4023-8e92-22a962df3aad | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Chain Drug Marketing Association | 86ff4875-9007-4b7b-8f46-16cbd475d4bb | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Clear Anti-Itch | PRAMOXINE HCL, ZINC ACETATE | Chain Drug Marketing Association | 1ff6bd85-3658-47ea-b6ca-0eb5d8dbb693 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | Chain Drug Marketing Association | 6c848b98-f01c-40f2-a9aa-2af76cb370c8 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | The Kroger Co. | fcffbe1f-79b8-451a-9384-19533b81d8c8 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | The Kroger Co. | d2095c7b-61ca-40d3-bbf1-04bed4dd789c | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | The Kroger Co. | ea8b186c-82d5-4552-bcce-03e56023ea99 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Diaper Rash Cream | ZINC OXIDE | Smalls Brand LLC DBA Roe Wellness | 4bd29285-29b4-5d57-e063-6294a90af481 | 2026-02-27 | Warnings | M016 |
| Vitamin A D | LANOLIN, PETROLATUM | Walmart Inc. | 5893801a-25e1-4750-a55b-d9cddd3f1284 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Walmart Inc. | 320bcbd3-9e91-437f-99c5-066f880a4b32 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Skin Protectant | PETROLATUM | Walmart Inc. | eb836922-f467-42ab-a6e7-b787d97e6c17 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Walmart Inc. | aa7dbf7f-50be-475b-8140-68be3fa93507 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| White Petrolatum | WHITE PETROLATUM | Walmart Inc. | 176d7711-7c4f-4319-91af-0aba1260c412 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Soothing Moisturizing | COLLOIDAL OATMEAL | Walmart Inc. | 2d813455-c268-4c6d-9952-eaf0e0007d90 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Rapid Repair Healing Cream | ALLANTOIN, DIMETHICONE | June Jacobs Labs LLC | 186c13be-5e41-b9c9-e063-6294a90ad574 | 2026-02-26 | Warnings | M016 |
| Lanashield | LANOLIN | Dynarex Corporation | 94b277dc-6512-4d36-8485-8ea510097428 | 2026-02-26 | Warnings | M016 |
| GLADSKIN ECZEMACT ECZEMA | COLLOIDAL OATMEAL | Micreos North America, Inc. | 06f9af75-c5ff-d37b-e063-6394a90a4f6c | 2026-02-25 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1234532 | calamine 8 % / pramoxine HCl 1 % Topical Lotion | PSN | 9089e23e-ca4a-454f-8dcc-ff5a29a5a335 | 3 |
| 1234532 | calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion | SCD | 9089e23e-ca4a-454f-8dcc-ff5a29a5a335 | 3 |
| 1234532 | calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion | SY | 9089e23e-ca4a-454f-8dcc-ff5a29a5a335 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 11344-136-30 | 11344013630 | 177 mL in 1 BOTTLE, PLASTIC (11344-136-30) | 177 ml | 2016-09-08 | No | No | Current |