NICODERM
- Product NDC
- 0135-0194
- 11-digit product format
- 001350194
- Labeler code
- 0135
- Product ID
- 0135-0194_39e81d62-9ad8-8f7f-e063-6394a90a17b2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- nicotine
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Haleon US Holdings LLC
- Application
- NDA020165
- Marketing category
- NDA
- Marketing start
- 2011-05-12
- Substance
- NICOTINE
- Active strength
- 21 mg/24h
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NICODERM
- Brand name suffix
- CQ
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NICOTINE | 21 mg/24h |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 198029, 198030, 198031, 351427, 351429, 351433 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0135-0194-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-53bd-111a-e063-dadaa90a10e2 | Drug Facts |
| 0135-0194-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-53bd-111a-e063-dadaa90a10e2 | Drug Facts |
| 0135-0194-03 | 2024-01-30 | C162847 | 48780-1 | 1030e365-53bd-111a-e063-dadaa90a10e2 | Drug Facts |
| 0135-0194-05 | 2024-01-30 | C162847 | 48780-1 | 1030e365-53bd-111a-e063-dadaa90a10e2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0194-01 | NICODERMCQ | 24 h in 1 PATCH | PATCH, EXTENDED RELEASE | 24 | 14 | |
| 0135-0194-01 | NICODERMCQ | 7 in 1 CARTON | PATCH, EXTENDED RELEASE | 7 | 14 | |
| 0135-0194-02 | NICODERMCQ | 24 h in 1 PATCH | PATCH, EXTENDED RELEASE | 24 | 14 | |
| 0135-0194-02 | NICODERMCQ | 14 in 1 CARTON | PATCH, EXTENDED RELEASE | 14 | 14 | |
| 0135-0194-03 | NICODERMCQ | 1 in 1 PACKAGE | PATCH, EXTENDED RELEASE | 1 | 14 | |
| 0135-0194-03 | NICODERMCQ | 21 in 1 CARTON | PATCH, EXTENDED RELEASE | 21 | 14 | |
| 0135-0194-05 | NICODERMCQ | 14 in 1 CARTON | PATCH, EXTENDED RELEASE | 14 | 14 | |
| 0135-0194-08 | NICODERMCQ | 24 h in 1 PATCH | PATCH, EXTENDED RELEASE | 24 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0194-01 | EA - Each | 0135-0194 | 764c561d-0286-41c7-8803-a84b913ac63c | 1 | 2012-07-24 |
| 0135-0194-02 | EA - Each | 0135-0194 | ed1b78a8-f9d2-4184-9f11-ca2887f29409 | 1 | 2012-07-24 |
| 0135-0194-03 | EA - Each | 0135-0194 | 5fa417a3-c62e-4436-bd7b-d75721ec0f5c | 1 | 2014-06-03 |
| 0135-0194-05 | EA - Each | 0135-0194 | afb31bf6-e1ae-4c33-83c1-44178201df75 | 1 | 2014-06-03 |
| 0135-0194-08 | EA - Each | 0135-0194 | e311bc3a-9018-4bab-bf70-37b3e89496e2 | 1 | 2024-01-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| NICOTINE | ACTIVE INGREDIENT | 6M3C89ZY6R | NICODERM CQ (NICOTINE) PATCH, EXTENDED RELEASE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP] | 5 | |
| NICOTINE | ACTIVE MOIETY | 6M3C89ZY6R | NICODERM CQ (NICOTINE) PATCH, EXTENDED RELEASE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP] | 5 | |
| ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) | INACTIVE INGREDIENT | L5F16ZG4ZU | NICODERM CQ (NICOTINE) PATCH, EXTENDED RELEASE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP] | 5 | |
| HIGH DENSITY POLYETHYLENE | INACTIVE INGREDIENT | UG00KM4WR7 | NICODERM CQ (NICOTINE) PATCH, EXTENDED RELEASE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP] | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 351429 | NICODERM CQ (Step 1) 21 MG/Day 24HR Transdermal System | PSN | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351427 | NICODERM CQ (Step 2) 14 MG/Day 24HR Transdermal System | PSN | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351433 | NICODERM CQ (Step 3) 7 MG/Day 24HR Transdermal System | PSN | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 198029 | nicotine 14 MG/Day 24HR Transdermal System | PSN | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 198030 | nicotine 21 MG/Day 24HR Transdermal System | PSN | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 198031 | nicotine 7 MG/Day 24HR Transdermal System | PSN | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351433 | 24 HR nicotine 0.292 MG/HR Transdermal System [Nicoderm C-Q] | SBD | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351427 | 24 HR nicotine 0.583 MG/HR Transdermal System [Nicoderm C-Q] | SBD | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351429 | 24 HR nicotine 0.875 MG/HR Transdermal System [Nicoderm C-Q] | SBD | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 198031 | 24 HR nicotine 0.292 MG/HR Transdermal System | SCD | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 198029 | 24 HR nicotine 0.583 MG/HR Transdermal System | SCD | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 198030 | 24 HR nicotine 0.875 MG/HR Transdermal System | SCD | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351433 | 24 HR Nicoderm C-Q 0.292 MG/HR Transdermal System | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351427 | 24 HR Nicoderm C-Q 0.583 MG/HR Transdermal System | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351429 | 24 HR Nicoderm C-Q 0.875 MG/HR Transdermal System | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351433 | Nicoderm C-Q 0.292 MG/HR 24HR Transdermal Patch | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351427 | Nicoderm C-Q 0.583 MG/HR 24HR Transdermal Patch | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351429 | Nicoderm C-Q 0.875 MG/HR 24HR Transdermal Patch | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351429 | Nicoderm CQ (Step 1) 21 MG/Day 24HR Transdermal Patch | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351429 | NICODERM CQ (Step 1) 21 MG/Day 24HR Transdermal System | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351427 | Nicoderm CQ (Step 2) 14 MG/Day 24HR Transdermal Patch | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351427 | NICODERM CQ (Step 2) 14 MG/Day 24HR Transdermal System | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351433 | Nicoderm CQ (Step 3) 7 MG/Day 24HR Transdermal Patch | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 351433 | NICODERM CQ (Step 3) 7 MG/Day 24HR Transdermal System | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 198031 | nicotine 0.292 MG/HR 24HR Transdermal Patch | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 198029 | nicotine 0.583 MG/HR 24HR Transdermal Patch | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 198030 | nicotine 0.875 MG/HR 24HR Transdermal Patch | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 198029 | nicotine 14 MG per 24HR 1 Day Transdermal Patch | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 198029 | nicotine 14 MG/Day 24HR Transdermal System | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 198030 | nicotine 21 MG per 24HR 1 Day Transdermal Patch | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 198030 | nicotine 21 MG/Day 24HR Transdermal System | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 198031 | nicotine 7 MG per 24HR 1 Day Transdermal Patch | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
| 198031 | nicotine 7 MG/Day 24HR Transdermal System | SY | 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0135-0194-01 | 00135019401 | 7 PATCH in 1 CARTON (0135-0194-01) / 24 h in 1 PATCH | 7 patch | 2011-05-12 | 0000-00-00 | No | No | Current |
| 0135-0194-02 | 00135019402 | 14 PATCH in 1 CARTON (0135-0194-02) / 24 h in 1 PATCH | 14 patch | 2011-05-12 | 0000-00-00 | No | No | Current |
| 0135-0194-03 | 00135019403 | 1 CARTON in 1 PACKAGE (0135-0194-03) / 21 PATCH in 1 CARTON / 24 h in 1 PATCH | 1 carton | 2011-05-12 | 0000-00-00 | No | No | Current |
| 0135-0194-05 | 00135019405 | 14 PATCH in 1 CARTON (0135-0194-05) / 24 h in 1 PATCH (0135-0194-08) | 14 patch | 2011-05-12 | 0000-00-00 | No | No | Current |
| 0135-0194-08 | 00135019408 | 24 h in 1 PATCH | 24 h | Historical |