Nicotine Patches
- Product NDC
- 85333-005
- 11-digit product format
- 853330005
- Labeler code
- 85333
- Product ID
- 85333-005_4d46110b-5aa8-5261-e063-6394a90a423a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Patches
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Zhejiang FTA Shengzuozhi Biotechnology Co., LTD
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-03-18
- Substance
- NICOTINE
- Active strength
- 7 mg/7mg
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- 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
- Nicotine Patches
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NICOTINE | 7 mg/7mg |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6M3C89ZY6R | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198031 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4d46110b-5aa7-5261-e063-6394a90a423a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85333-005-02 | Nicotine Patches | 21 mg in 1 PATCH | PATCH | 21 | 1 | |
| 85333-005-02 | Nicotine Patches | 14 in 1 BOX | PATCH | 14 | 1 |
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 |
|---|---|---|---|---|---|---|
| Pediadermics eczema 3 | COLLOIDAL OATMEAL, DIMETHICONE | Renu Laboratories, LLC | af861f0b-4387-6861-e053-2995a90a8bfa | 2025-12-02 | Warnings | M016 |
| Flexitol Face and Eyelid Eczema | OATMEAL | LaCorium Health USA Inc. | f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee65 | 2025-12-02 | Warnings | M016 |
| ProCure HydroShield | PETROLATUM 41% | Twin Med LLC | 3d36e664-ac10-72eb-e063-6294a90a49c4 | 2025-12-01 | Warnings | M016 |
| ProCure Vitamin A and D | WHITE PETROLATUM 93.4% | Twin Med LLC | 3d385a07-2a12-fce7-e063-6294a90a32d6 | 2025-12-01 | Warnings | M016 |
| ESTRIOL | ESTRIOL | Shenzhen Mengyue Technology Co., Ltd. | 44de9eb4-080e-bfbc-e063-6394a90ac0ea | 2025-12-01 | Warnings | M016 |
| CareALL Creamy Petroleum Jelly | PETROLATUM | New World Imports, Inc | e13fea4e-bd6d-425a-aa7e-1d41dc36bf00 | 2025-12-01 | Warnings | M016 |
| CareALL Creamy Cocoa Butter Petroleum Jelly | PETROLATUM | New World Imports, Inc | 9358b8ef-df14-45fc-9bfd-9052577a1f88 | 2025-12-01 | Warnings | M016 |
| CAREALL Zinc Oxide | ZINC OXIDE | New World Imports Inc | aa9ae4d1-4229-4894-9eaf-8588b2867472 | 2025-12-01 | Warnings | M016 |
| CAREALL Petroleum | PETROLATUM | New World Imports, Inc | 47e999de-08bd-4121-b6d0-270cc603b56d | 2025-12-01 | Warnings | M016 |
| HOEGOA Growth Hair Serum | GLYCERIN | Shantou Oralhoe Biotechnology Co., Ltd. | 44b6609f-c58b-b6ac-e063-6394a90a749b | 2025-11-29 | Warnings | M016 |
| OUHOE Micro Darts Tag gone Patch | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 33ce447c-facd-35fb-e063-6394a90a1ead | 2025-11-27 | Warnings | M016 |
| OUHOE Herbal Hair Oil | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 30c3df30-e0c6-4efa-e063-6294a90ac40a | 2025-11-27 | Warnings | M016 |
| OUHOE Aloe Soothing Sun Cream | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 326781e0-55dc-80fc-e063-6394a90a09aa | 2025-11-27 | Warnings | M016 |
| OUHOE Ultra Anti-Acne Control Gel | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 3bd1b734-76b0-5264-e063-6294a90a32d0 | 2025-11-27 | Warnings | M016 |
| OUHOE Lipoma Cream | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 3cb4aed1-3b13-a62a-e063-6294a90a6c39 | 2025-11-27 | Warnings | M016 |
| OUHOE Para Crescimento | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 42fbfcac-29ab-51f7-e063-6394a90a626f | 2025-11-27 | Warnings | M016 |
| OUHOE Biotin With Hydrolyzed Collagen | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 43138915-5fe1-6e32-e063-6294a90abefa | 2025-11-27 | Warnings | M016 |
| EELHOE Pain Relief Patch | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3f835843-eb04-6273-e063-6294a90ab2f0 | 2025-11-27 | Warnings | M016 |
| EELHOE Skin Tag Remover | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 32922508-74ae-8347-e063-6294a90a6154 | 2025-11-27 | Warnings | M016 |
| EELHOE Bodyacne Removal Cleanser | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3bbebf1d-2e22-1427-e063-6294a90a7999 | 2025-11-27 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198031 | nicotine 7 MG/Day 24HR Transdermal System | PSN | 4d46110b-5aa7-5261-e063-6394a90a423a | 1 |
| 198031 | 24 HR nicotine 0.292 MG/HR Transdermal System | SCD | 4d46110b-5aa7-5261-e063-6394a90a423a | 1 |
| 198031 | nicotine 0.292 MG/HR 24HR Transdermal Patch | SY | 4d46110b-5aa7-5261-e063-6394a90a423a | 1 |
| 198031 | nicotine 7 MG per 24HR 1 Day Transdermal Patch | SY | 4d46110b-5aa7-5261-e063-6394a90a423a | 1 |
| 198031 | nicotine 7 MG/Day 24HR Transdermal System | SY | 4d46110b-5aa7-5261-e063-6394a90a423a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85333-005-02 | 85333000502 | 14 PATCH in 1 BOX (85333-005-02) / 21 mg in 1 PATCH | 14 patch | 2026-03-18 | No | No | Current |