NicFix

Product NDC
42638-7663
11-digit product format
426387663
Labeler code
42638
Product ID
42638-7663_9a75311e-6f33-4772-878f-d50b2372a21f
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine
Dosage form
LIQUID
Route
ORAL
Labeler
Nico Worldwide, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-01-09
Marketing end
0000-00-00
Substance
NICOTINE; TYROSINE; PHENYLALANINE; TRYPTOPHAN; CAFFEINE; CITRIC ACID MONOHYDRATE
Active strength
3 mg/60000mg; mg/60000mg; mg/60000mg; mg/60000mg; mg/60000mg; mg/60000mg
NDC exclude flag
E
Listing certified through
2017-12-31
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42638-7663IInactivated by FDA2026-10-05
excluded packagepackage42638-766342638-7663-2IInactivated by FDA2026-10-05

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.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42638-7663-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42638-7663-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42638-7663-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42638-7663-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42638-7663-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42638-7663-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42638-7663-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42638-7663-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42638-7663-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42638-7663-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42638-7663-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42638-7663-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42638-7663-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42638-7663-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42638-7663-21332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42638-7663-2fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42638-7663-286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42638-7663-2bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42638-7663-28dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42638-7663-2e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42638-7663-29bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42638-7663-2110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42638-7663-22019-11-27C16284748780-19855e2a2-4f89-60a7-e053-dbdaa90a05bd00a58408-97c6-4e08-9595-da4b8653b956

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42638-7663-2NicFix60000 mg in 1 BOTTLE, UNIT-DOSELIQUID600002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAFFEINEACTIVE INGREDIENT3G6A5W338ENICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2
CITRIC ACID MONOHYDRATEACTIVE INGREDIENT2968PHW8QPNICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2
PHENYLALANINEACTIVE INGREDIENT47E5O17Y3RNICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2
TRYPTOPHANACTIVE INGREDIENT8DUH1N11BXNICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2
TYROSINEACTIVE INGREDIENT42HK56048UNICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLNICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2
CAFFEINEACTIVE MOIETY3G6A5W338ENICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2
NICOTINEACTIVE MOIETY6M3C89ZY6RNICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2
PHENYLALANINEACTIVE MOIETY47E5O17Y3RNICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2
TRYPTOPHANACTIVE MOIETY8DUH1N11BXNICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2
TYROSINEACTIVE MOIETY42HK56048UNICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2
SIRAITIA GROSVENORII FRUITINACTIVE INGREDIENTNOU2FB51TWNICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUNICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4NICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RNICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42638-7663NICFIX (NICOTINE) LIQUID [NICO WORLDWIDE, INC.]2Legacy NDC, 1 package rows20140127_00a58408-97c6-4e08-9595-da4b8653b956.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42638-7663-24263876630260000 mg in 1 BOTTLE, UNIT-DOSE60000 mgHistorical