multipurpose
- Product NDC
- 16864-041
- 11-digit product format
- 168640041
- Labeler code
- 16864
- Product ID
- 16864-041_4d63eb8d-9dec-031c-e063-6294a90a74ca
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide Skin Protectant
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Advantice Health, LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-09-16
- Substance
- ZINC OXIDE
- Active strength
- 12.8 g/100g
- 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
- multipurpose
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 12.8 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 637168 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 291563cc-7491-ce41-e063-6394a90ac6c1 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16864-041-01 | multipurpose | 1 in 1 CARTON | OINTMENT | 1 | 2 | |
| 16864-041-01 | multipurpose | 56 g in 1 TUBE | OINTMENT | 56 | 2 |
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 |
|---|---|---|---|---|---|---|
| Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Pharma Nobis, LLC | e42fccc2-1b4e-e7f3-e053-2a95a90aef39 | 2023-12-26 | Warnings | M016 |
| Calamine Phenolated Topical Suspension | CALAMINE AND ZINC OXIDE AND PHENOL | Pharma Nobis, LLC | e42fbdcc-3291-7761-e053-2995a90a7172 | 2023-12-26 | Warnings | M016 |
| Humco Calagesic | CALAMINE AND PRAMOXINE HYDROCHLORIDE | Pharma Nobis, LLC | e42fb807-8cb4-ed25-e053-2995a90a6780 | 2023-12-26 | Warnings | M016 |
| Leader Calamine Plus | ZINC OXIDE LOTION | Cardinal Health, 110 dba Leader | 81f29789-f794-1e64-e053-2a91aa0ac85e | 2023-12-22 | Warnings | M016 |
| CVS Calamine Plus | ZINC OXIDE | CVS Pharmacy | b90cd214-d44a-4458-876d-59cc0795226d | 2023-12-22 | Warnings | M016 |
| Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Pharma Nobis, LLC | e42f0bd6-3ad3-7e07-e053-2995a90a564a | 2023-12-22 | Warnings | M016 |
| DDM Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Discount Drug Mart | 5d53685b-ca4c-35c1-e053-2a91aa0aff6e | 2023-12-20 | Warnings | M016 |
| DDM Calagesic | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Discount Drug Mart | 5d537a11-049e-0a8d-e053-2a91aa0aa0c3 | 2023-12-20 | Warnings | M016 |
| Health Mart Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Strategic Sourcing Services LLC | 349ea07d-79bc-46f3-9d60-85b40db51bbb | 2023-12-20 | Warnings | M016 |
| Health Mart Witch Hazel | WITCH HAZEL | Strategic Sourcing Services LLC | 2a1d9b27-0bd4-4475-8218-ba0f5560a969 | 2023-12-20 | Warnings | M016 |
| Quality Choice Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Chain Drug Market Association | 62fe653f-e861-472b-b193-4fdd9d25de8d | 2023-12-20 | Warnings | M016 |
| Premier Value Calaclear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Chain Drug Consortium | 5c89e3ac-ca4d-ec3a-e053-2a91aa0a1c0b | 2023-12-20 | Warnings | M016 |
| Best Choice Medicated Calamine | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Valu Merchandisers, CO. | 5d6c668a-80b4-de18-e053-2991aa0a38fb | 2023-12-20 | Warnings | M016 |
| Premiere Value Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Chain Drug Consortium | 5c8bde5a-591d-085f-e053-2991aa0a56af | 2023-12-20 | Warnings | M016 |
| Best Choice Anti-Itch Clear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Valu Merchandisers, CO | 5d6c51b8-47f8-c38b-e053-2991aa0a0f23 | 2023-12-20 | Warnings | M016 |
| Health Care Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Great Lakes Wholesale, Marketing and Sales Inc | 5d8f02fb-0794-8ec2-e053-2991aa0aac63 | 2023-12-20 | Warnings | M016 |
| Harris Teetter Calagesic | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Harris Tetter, LLC. | 5c7a7418-c973-2869-e053-2991aa0ab4f5 | 2023-12-20 | Warnings | M016 |
| Harris Teeter Calamine | ZINC OXIDE | Harris Teeter, LLC. | 86021cc5-fea7-4363-8fb2-2b0484437fe8 | 2023-12-20 | Warnings | M016 |
| CVS Itch Relief | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | CVS Pharmacy | c60cfbf2-6788-43dc-b23a-e3433b7f3265 | 2023-12-20 | Warnings | M016 |
| Sunmark Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Strategic Sourcing Services LLC | c7467f21-56cc-43ca-abfa-e62d35c8baa6 | 2023-12-19 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 637168 | zinc oxide 12.8 % Topical Ointment | PSN | 291563cc-7491-ce41-e063-6394a90ac6c1 | 2 |
| 637168 | zinc oxide 0.128 MG/MG Topical Ointment | SCD | 291563cc-7491-ce41-e063-6394a90ac6c1 | 2 |
| 637168 | zinc oxide 12.8 % Topical Ointment | SY | 291563cc-7491-ce41-e063-6394a90ac6c1 | 2 |
| 637168 | ZNO 0.128 MG/MG Topical Ointment | SY | 291563cc-7491-ce41-e063-6394a90ac6c1 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 16864-041-01 | 16864004101 | 1 TUBE in 1 CARTON (16864-041-01) / 56 g in 1 TUBE | 1 tube | 2024-09-16 | No | No | Current |