Tru Relief Nicotine

Product NDC
0113-6000
11-digit product format
001136000
Labeler code
0113
Product ID
0113-6000_8dee28c9-39c3-48e2-a674-5b7eab92c5e6
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA203690
Marketing category
ANDA
Marketing start
2016-12-01
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
2 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0113-6000DDiscontinued by firm2026-07-31
excluded packagepackage0113-60000113-6000-07DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203690-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09
A203690-002NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nicotineNICOTINE POLACRILEXPublix Super Markets Incfd93fdf4-fa48-4373-aac7-894866a0b18d2026-07-22WarningsExact identifier
nicotineNICOTINE POLACRILEXPublix Super Markets Inc31b1a48e-8651-41d7-b693-6509a344906a2026-07-20WarningsExact identifier
Mini NicotineNICOTINE POLACRILEXRite Aid Corporation353221c6-96c7-4c4b-a114-03e71d2114f82026-07-07WarningsExact identifier
DG HEALTH NICOTINENICOTINE POLACRILEXDolgencorp Incb44f0525-abf6-461d-ae15-40d162021eaa2026-07-01WarningsExact identifier
NICOTINE MININICOTINE POLACRILEXAmazon.com Services LLCd6f7dea2-6375-4057-8947-314a429fa4922026-06-23WarningsExact identifier
BLIPNICOTINE POLACRILEXBlip Products, Inc.e48ba1fe-a9ad-4ff3-8f73-e08ae40724542026-05-27WarningsExact identifier
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC8b6d7617-ce92-4bad-9f38-81a7f2e9cfa32026-05-27WarningsExact identifier
BLIPNICOTINE POLACRILEXBlip Products, Inc.40e2b0e1-e049-4ec5-a4a8-138ad80b84202026-05-27WarningsExact identifier
nicotine miniNICOTINE POLACRILEXWalgreen Company95799f41-aa5c-4540-8b90-5f5ebe1363322026-05-15WarningsExact identifier
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC71d1dcd2-e046-49ad-a28a-90e550a711042026-05-11WarningsExact identifier
GOOD SENSE NICOTINENICOTINE POLACRILEXL. Perrigo Company632283a5-c617-4759-8933-7dc015e551c72026-05-11WarningsExact identifier
Nicotine PolacrilexNICOTINE POLACRILEXPadagis Israel Pharmaceuticals Ltdb765570e-e5b5-48e4-b4d2-2a85ac19a2ea2026-04-30WarningsExact identifier
up and up citrus mini nicotineNICOTINE POLACRILEXTarget Corporation9c2ee4fb-bb6f-4703-8519-8f4b175dafad2026-04-27WarningsExact identifier
nicotineNICOTINE POLACRILEXCVS Pharmacy0837132a-a557-4e35-ad08-250b2c2fb6442026-04-16WarningsExact identifier
NicotineNICOTINE POLACRILEXCVS Pharmacy54b181ea-41fc-46b6-9611-5473973c82d92026-04-16WarningsExact identifier
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLCa0238a02-26eb-4cde-8ff7-a5f0d26dd1752026-04-16WarningsExact identifier
CareOne NicotineNICOTINE POLACRILEXAmerican Sales Company74ec6a60-eb3a-47d4-a11b-650b6418d37f2026-04-14WarningsExact identifier
up and up cherry ice nicotineNICOTINE POLACRILEXTarget Corporation99977d30-41ba-4237-920a-dbd5ad8fc3802026-04-14WarningsExact identifier
NicotineNICOTINE POLACRILEXCVS Pharmacy65ceb67b-dc22-4f5f-bfce-d6e957835eb32026-04-13WarningsExact identifier
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company1a7cfbdc-53cc-4cd2-86b2-6e27a7979abf2026-04-08WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

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. Ask a doctor before use if you have • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. • high blood pressure not controlled with medication. Nicotine can increase your blood pressure. • stomach ulcer or diabetes • history of seizures Ask a doctor or pharmacist before use if you are • using a non-nicotine stop smoking drug • taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. Stop use and ask a doctor if • mouth problems occur • persistent indigestion or severe sore throat occurs • irregular heartbeat or palpitations occur • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat • you have symptoms of an allergic reaction (such as difficulty breathing or rash) Keep out of reach of children and pets. Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).