warnings
Warnings
Nicotine
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Nicotine
- Generic name
- NICOTINE POLACRILEX
- Manufacturer
- H E B
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 056ca637-d5b9-4790-a5a4-c9b58f93e88b
- SPL ID
- 5ae26a58-b2e2-43dc-9e28-9e4bae1e558a
- Version
- 3
- Effective date
- 2026-04-02
- Source export date
- 2026-09-28
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:17:34
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 079219 | derived:openfda.application_number |
| application number | ANDA079219 | openfda.application_number | |
| brand name | Nicotine | openfda.brand_name | |
| generic name | NICOTINE POLACRILEX | openfda.generic_name | |
| manufacturer name | H E B | openfda.manufacturer_name | |
| ndc | package | 37808-821-16 | openfda.package_ndc |
| ndc | product | 37808-821 | openfda.product_ndc |
| ndc11 | package | 37808082116 | derived:openfda.package_ndc |
| rxcui | 311975 | openfda.rxcui | |
| spl id | 5ae26a58-b2e2-43dc-9e28-9e4bae1e558a | id | |
| spl set id | 056ca637-d5b9-4790-a5a4-c9b58f93e88b | set_id | |
| unii | 6M3C89ZY6R | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
If you are pregnant or breast-feeding only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. however, the risks to your child from this medicine are not fully known.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.