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 |
|---|---|---|---|---|---|---|
| Calamine | FERRIC OXIDE RED | Perrigo Direct, Inc | 256bd1d4-fd50-408f-9aee-84f218bb4971 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Perrigo Direct, Inc | e11470b2-80d6-4008-b87e-eb6aeadfce74 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Clear Anti-Itch | PRAMOXINE HCL, ZINC ACETATE | Perrigo Direct, Inc | cc0378f2-6d5f-47ec-b16a-64668b4c29cc | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXIND HCL | Perrigo Direct, Inc | 54a20ec9-ab86-4410-af94-e04393e9d4b3 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Vitamin A D | LANOLIN, PETROLATUM | Meijer, Inc. | adc3bb9b-ed8a-4b65-b44c-1d1e978c89ec | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Meijer, Inc. | 1b72f927-c2ae-4190-a035-5d7bb9f53c15 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | Meijer, Inc. | af293cc0-ccd5-42a6-861b-c19fa6ffd06a | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Healing for Babies | PETROLATUM | Meijer, Inc. | 09878fe0-0890-4af3-a3f6-d2890041e9f8 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Clear Anti-Itch | PRAMOXINE HCL, ZINC ACETATE | Meijer, Inc. | fa8ae34c-7b68-454f-8a3b-0eaa93a34092 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Baby Diaper Rash | ZINC OXIDE | Meijer, Inc. | 04bec667-a11e-42d2-a4b3-1416eebf1e8d | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Healing | PETROLATUM | Meijer, Inc. | 8cb56ee4-b9d1-4a29-88c7-e6f3ac2112c1 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | Meijer, Inc. | 6b369ef2-fd54-4931-a9eb-0fb42834c2ef | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Dimethicone | DIMETHICONE | Meijer, Inc. | 75b91b97-ea84-4c4d-9e58-5a9ff27a778c | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Colloidal oatmeal | COLLOIDAL OATMEAL | Meijer, Inc. | d36a7479-7b3b-49fe-8144-b5cce0e173fb | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DAILY MOISTURIZING | Meijer, Inc. | 44949b46-70f2-4e52-adba-a8455da614eb | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Meijer, Inc. | 13e4aece-5b91-4f89-a912-540bf170a8d1 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Target Corporation | 7fb5f9ca-cd90-4933-9fe8-907ece00458b | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Target Corporation | d4ee05c8-ae62-45df-8783-1ed57fa030ec | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Target Corporation | 5237c7f2-7135-4558-a758-4fc2a232172f | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Target Corporation | 3e620e4f-9e29-9e39-e063-6394a90adeda | 2026-02-18 | Warnings, Adverse reactions | 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 |