Poison Ivy/Oak
- Product NDC
- 82960-022
- 11-digit product format
- 829600022
- Labeler code
- 82960
- Product ID
- 82960-022_e900927a-7b3e-20a8-e053-2a95a90a5fd1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Kaolin, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Rosemont Ventures, Inc.
- Application
- M016
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-09-15
- Marketing end
- 0000-00-00
- Substance
- KAOLIN; ZINC OXIDE
- Active strength
- 4 g/100mL; g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 82960-022 | D | Discontinued by firm | 2026-10-21 | ||
| excluded package | package | 82960-022 | 82960-022-01 | D | Discontinued by firm | 2026-10-21 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 82960-022-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 82960-022-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 82960-022-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 82960-022-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 82960-022-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 82960-022-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 82960-022-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 82960-022-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 82960-022-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 82960-022-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 82960-022-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 82960-022-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
|---|---|---|---|---|---|---|
| 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 |
| Sunmark Witch Hazel | WITCH HAZEL | Strategic Sourcing Services LLC | 08c00c1a-7ec8-4624-9db0-a0e8430cd126 | 2023-12-19 | Warnings | M016 |
| Sunmark Caldyphen Clear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 329cd4ef-b699-46ff-a5d6-907f7c327c03 | 2023-12-19 | Warnings | M016 |
| DDM Calaclear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Discount Drug Mart | 5d536077-b5c6-29b8-e053-2a91aa0a9ae1 | 2023-12-19 | Warnings | M016 |
| Sunmark Phenolated Calamine | CALAMINE AND ZINC OXIDE AND PHENOL | Strategic Sourcing Services LLC | 8e68efc4-4c95-41c0-9fed-32297b1b2edc | 2023-12-19 | Warnings | M016 |
| Calm and Heal Melting Balm | ALLANTOIN | The Honest Company, Inc. | b08a1bd6-986d-9520-e053-2995a90a865e | 2023-12-19 | Warnings | M016 |
| TopCare Calagesic | CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION | TOPCO ASSOCIATES LLC | 8dced3ea-147b-3d46-e053-2a95a90aa1c0 | 2023-12-18 | Warnings | M016 |
| TopCare Calamine | CALAMINE 8% AND ZINC OXIDE 8% LOTION | TOPCO ASSOCIATES LLC | 8dcf134e-0427-0c43-e053-2995a90a7c26 | 2023-12-18 | Warnings | M016 |
| HEB Calaclear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | H E B | 5d576794-88d1-484a-e053-2991aa0aa479 | 2023-12-18 | Warnings | M016 |
| Publix Calamine Medicated | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Publix | 5d6ba4cf-f2cb-0ecb-e053-2991aa0a5673 | 2023-12-18 | Warnings | M016 |
| TopCare Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | TOPCO ASSOCIATES LLC | 8dce8817-b905-4064-e053-2995a90a071e | 2023-12-18 | Warnings | M016 |
| Assured Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Greenbriar International | 9d378cc5-9af0-1389-e053-2995a90a0b96 | 2023-12-18 | Warnings | M016 |
| HEB Calagesic | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | H E B | 5d579680-6bcb-1161-e053-2991aa0aead1 | 2023-12-18 | Warnings | M016 |
| Publix Clear Anti-Itch | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Publix | 5d6b905f-ed30-1ab7-e053-2a91aa0a816b | 2023-12-18 | Warnings | M016 |
| Humco Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Humco Holding Group, Inc. | 5fca3a73-6d66-496b-bd33-6e044f9039bc | 2023-12-15 | Warnings | M016 |
| Calamine Phenolated Topical Suspension | CALAMINE AND ZINC OXIDE AND PHENOL | Humco Holding Group, Inc | a3816729-be2b-4b4f-a609-953576cd2e3b | 2023-12-15 | Warnings | M016 |
| Humco Mineral Oil Light | MINERAL OIL | Humco Holding Group, Inc. | 753f35c3-1420-4817-ba63-b737a9c99a1d | 2023-12-15 | Warnings | M016 |
| Humco Witch Hazel | WITCH HAZEL | Humco Holding Group, Inc. | 3cf07016-a129-49ca-8fad-b67dda5aa009 | 2023-12-15 | Warnings | M016 |
| Rite Aid Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Rite Aid Corporation | 5df71189-9b36-9dee-e053-2a91aa0a9e49 | 2023-12-15 | Warnings | M016 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 82960-022-01 | 82960002201 | 1 TUBE in 1 CARTON (82960-022-01) > 59 mL in 1 TUBE | 1 tube | 2022-09-15 | 0000-00-00 | No | No | Current |