Assured Calamine
- Product NDC
- 33992-4130
- 11-digit product format
- 339924130
- Labeler code
- 33992
- Product ID
- 33992-4130_0ccb40f9-0734-b059-e063-6394a90aa03c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine 8% and Zinc Oxide 8%
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Greenbriar International
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-01-27
- Substance
- ZINC OXIDE
- Active strength
- 160 mg/mL
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- Assured Calamine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 160 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 617954 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9d378cc5-9af0-1389-e053-2995a90a0b96 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33992-4130-6 | Assured Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 33992-4130 | ASSURED CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [GREENBRIAR INTERNATIONAL] | 3 | Current NDC, Legacy NDC, 1 package rows | 20231219_9d378cc5-9af0-1389-e053-2995a90a0b96.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 |
|---|---|---|---|---|---|---|
| First Aid Beauty FAB Ultra Repair Body Skin Protectant | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 1a9d86fc-ef32-baed-e063-6394a90a7d74 | 2026-03-12 | Warnings | M016 |
| Meijer Scar Gel | ALLANTOIN 0.5% | Meijer | 4c108c34-72f3-1382-e063-6394a90a7f2c | 2026-03-11 | Warnings | M016 |
| E2 hand wash | E2 SANITIZING HAND SOAP | Horizon Tool Inc. | a40afa46-a07d-f864-e053-2a95a90aef8a | 2026-03-11 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Skin Protectant Sugar Cookie | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 4576cd28-9530-4db4-e063-6394a90a9fd3 | 2026-03-10 | Warnings | M016 |
| Diaper Rash | ZINC OXIDE | Lidl US, LLC | e399b33f-5f7c-47eb-8e9b-1721ae4680b5 | 2026-03-10 | Warnings, Adverse reactions | M016 |
| Vitamin A D | WHITE PETROLATUM | Sion Biotext Medical Ltd. | 503c4ab9-1f60-48e2-af47-7ef996466a5b | 2026-03-09 | Warnings | M016 |
| Trstay | RETINOL SERUM | Shenzhen yuehaotong Technology Co.,Ltd | 4c6e20dd-0a71-a96b-e063-6294a90ab833 | 2026-03-07 | Warnings | M016 |
| 2-Pack Facial Serum | 2-PACK FACIAL SERUM | Guangzhou Ariel Biotech Co., Ltd. | 27c7f645-cfb3-6db1-e063-6394a90a42ff | 2026-03-06 | Warnings | M016 |
| 2-Pack Facial Serum | 2-PACK FACIAL SERUM | Guangzhou Ariel Biotech Co., Ltd. | 27c89fc6-016b-d359-e063-6394a90a5602 | 2026-03-06 | Warnings | M016 |
| Boudreauxs | ZINC OXIDE | C.B. Fleet Company, Inc. | f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a | 2026-03-06 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant | DIMETHICONE | The Procter & Gamble Manufacturing Company | 276c68d4-e273-4e48-e063-6294a90ab16f | 2026-03-04 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 4c1d00b3-313b-933f-e063-6294a90ac46f | 2026-03-03 | Warnings | M016 |
| Zinc Oxide | ZINC OXIDE | Amazon.com Services LLC | 495fffd7-7b64-954a-e063-6394a90a81fd | 2026-03-03 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | Amazon.com Services LLC | aceb0b10-8c90-4a06-8c47-cd1a2b4676a3 | 2026-03-03 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Amazon.com Services LLC | 134e07a1-5236-4088-baf9-1ff33126f793 | 2026-03-03 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Old East Main Co. | 7f56ab98-dbd8-412a-8c31-bb6302b7f329 | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Old East Main Co. | c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Old East Main Co. | ae8583c0-1b52-461d-8506-ec7524f1b4c4 | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Healing for Babies | PETROLATUM | Old East Main Co. | aa1acc24-56af-4708-bf76-23d4de3d089e | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Old East Main Co. | de8d8071-ecb2-4719-8c7b-7944f27810d6 | 2026-03-02 | Warnings, Adverse reactions | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | PSN | 9d378cc5-9af0-1389-e053-2995a90a0b96 | 3 |
| 617954 | calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion | SCD | 9d378cc5-9af0-1389-e053-2995a90a0b96 | 3 |
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | SY | 9d378cc5-9af0-1389-e053-2995a90a0b96 | 3 |
| 617954 | Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion | SY | 9d378cc5-9af0-1389-e053-2995a90a0b96 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 33992-4130-6 | 33992413006 | 177 mL in 1 BOTTLE, PLASTIC (33992-4130-6) | 177 ml | 2020-01-27 | 0000-00-00 | No | No | Current |