Calamine
- Product NDC
- 11344-063
- 11-digit product format
- 113440063
- Labeler code
- 11344
- Product ID
- 11344-063_5b85784d-fcef-31cf-e063-6294a90a42e7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine, Zinc oxide
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Nice-Pak Products, LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1989-07-15
- Substance
- FERRIC OXIDE RED; ZINC OXIDE
- Active strength
- 80; 80 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 |
| ZINC OXIDE | 80 mg/mL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11344-063-30 | 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 |
|---|---|---|---|---|---|---|
| Dove | CARE AND PROTECT ANTIBACTERIAL HAND WASH | Conopco Inc. d/b/a/ Unilever | ed234413-777a-9c82-e053-2a95a90a6f98 | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | CATCHING THE SUNRISE HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | b9fa6c72-7c56-6fd0-e053-2995a90a6707 | 2024-11-07 | Warnings | M016 |
| Dove | CARE AND PROTECT ANTIBACTERIAL FOAMING HAND WASH | Conopco Inc. d/b/a/ Unilever | ed24b320-27fc-9714-e053-2995a90a79a6 | 2024-11-07 | Warnings | M016 |
| SKINSEI | ETHYL ALCOHOL LIQUID | Conopco Inc. d/b/a/ Unilever | a603c419-238f-0bae-e053-2a95a90abc2b | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | UNDER THE STARLIT SKY HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0dfe52-c550-94fd-e053-2995a90a9800 | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | SUMMERTIME SPRINKLERS HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0e474c-db62-910f-e053-2995a90a889e | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | GIRLS NIGHT OUT HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0ce03e-5e7b-b09a-e053-2995a90a4eef | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | AFTER THE RAIN HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0d27fb-f72f-5e87-e053-2a95a90af7e0 | 2024-11-07 | Warnings | M016 |
| Love Beauty and Planet | BELOVED CATCUS FLOWER AND BASIL HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba47599c-3e11-cec3-e053-2a95a90aef7b | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | WRAPPED IN YOUR ARMS HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0ef938-da18-3b9c-e053-2995a90acb72 | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | SUNKISSED OCEAN WAVES HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0db6a3-222a-093f-e053-2a95a90ac88a | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | LAZY WEEKENDS HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0f4571-e752-d925-e053-2995a90afd3a | 2024-11-07 | Warnings | M016 |
| Love Beauty and Planet | BELOVED GREEN CLAY AND EUCALYPTUS HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba48b351-0d7f-5a41-e053-2a95a90a348c | 2024-11-07 | Warnings | M016 |
| Love Beauty and Planet | BELOVED COCONUT AND WARM VANILLA HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0ffbf9-7dd0-f685-e053-2995a90a0be0 | 2024-11-07 | Warnings | M016 |
| Love Beauty and Planet | BELOVED PATCHOULI AND ORANGE FLOWER HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba49e27b-1ade-a75a-e053-2a95a90a1843 | 2024-11-07 | Warnings | M016 |
| Love Beauty and Planet | BELOVED CHERRY BLOSSOM AND TEA ROSE HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba4979a3-ae30-42e4-e053-2995a90abfe7 | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | SWEET TREATS HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0fa3cb-8c25-7511-e053-2995a90a4287 | 2024-11-07 | Warnings | M016 |
| Love Beauty and Planet | BELOVED LAVENDER AND HYSSOP HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba484531-ef7b-17ed-e053-2995a90a50b3 | 2024-11-07 | Warnings | M016 |
| Love Beauty and Planet | BELOVED GRAPEFRUIT AND RED GINGER HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba4a573d-def4-a735-e053-2995a90a4f29 | 2024-11-07 | Warnings | M016 |
| Dove | HAND SANITIZER LAVENDER | Conopco Inc. d/b/a/ Unilever | ddcb0871-9903-125f-e053-2a95a90a75de | 2024-11-07 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | PSN | c370ee1f-1887-44e8-8d47-8ffa3c270ff5 | 3 |
| 617954 | calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion | SCD | c370ee1f-1887-44e8-8d47-8ffa3c270ff5 | 3 |
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | SY | c370ee1f-1887-44e8-8d47-8ffa3c270ff5 | 3 |
| 617954 | Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion | SY | c370ee1f-1887-44e8-8d47-8ffa3c270ff5 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 11344-063-30 | 11344006330 | 177 mL in 1 BOTTLE, PLASTIC (11344-063-30) | 177 ml | 1998-07-15 | No | No | Current |