Ditch The Itch
- Product NDC
- 82960-042
- Requested package NDC
- 82960-042-01
- 11-digit product format
- 829600042
- Labeler code
- 82960
- Product ID
- 82960-042_e8ffb8d4-6b3b-4488-e053-2995a90afd71
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Colloidal oatmeal
- 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
- OATMEAL
- Active strength
- 1 g/100mL
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
- 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 package | package | 82960-042 | 82960-042-01 | D | Discontinued by firm | 2026-10-23 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 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 |
|---|---|---|---|---|---|---|
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 82960-042-01 | 82960004201 | 1 TUBE in 1 CARTON (82960-042-01) > 59 mL in 1 TUBE | 1 tube | 2022-09-15 | 0000-00-00 | No | No | Current |