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(from DailyMed)

good neighbor pharmacy nicotine Nicotine polacrilex 4 mg Gum, Chewing

by Amerisource Bergen · 100 BLISTER PACK in 1 CARTON (46122-666-78) / 1 GUM, CHEWING in 1 BLISTER PACK
NDC 46122-0666-78
🏷️ FDA NDC (as labeled) 46122-666-78 billing pads the product segment with a zero
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Mar 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 46122-666-78
Product NDC 46122-666
11-digit billing NDC 46122066678
NCPDP billing unit EA — each (per item)
Application # ANDA078546
Chemical class Cholinergic Nicotinic Agonist [EPC], Nicotine
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Mar 2024)
Route ORAL
Dosage form GUM, CHEWING
Substance NICOTINE
GCN Seq No 013486
GCN 03201
HICL code 002049
Ingredient (HICL) Nicotine Polacrilex
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J3
Therapeutic class — intermediate (HIC2) Ganglionic Stimulants
HIC3 code J3A
Therapeutic class — specific (HIC3) Smoking Deterrent Agents (Ganglionic Stim,Others)
AHFS code 12:02.00.00
AHFS class Smoking Cessation Agents
FDB label name GNP NICOTINE 4 MG CHEWING GUM
FDB brand name Nicotine Gum
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 46122-666-78 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 46122-0666-78. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerAmerisource Bergen
Application holderPERRIGO R AND D CO
FDA applicationANDA078546 (ANDA)
Labeler code46122
Product typeHuman Otc Drug
Portfolio206 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name GNP NICOTINE 4 MG CHEWING GUM Ingredient Nicotine Polacrilex
📗 Our plain-language guide HelloPharmacist
  • It's a fair question. Nicotine is what makes cigarettes addictive, and it does raise your heart rate and blood pressure. But it's the thousands of other chemicals in cigarette smok...
  • Is nicotine replacement actually safe — isn't nicotine the thing that's bad for you?
  • It comes down to one simple question: when do you smoke your first cigarette of the day? If it's within 30 minutes of waking up, you're a heavier, more dependent smoker and you'll...
  • It depends on the form you're using. With the gum or lozenge, hiccups, heartburn, and a tingling in the mouth are pretty common — these usually mean you're using it a bit too fast....
📖 Read our full Nicotine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.282 $28.17 / 100 gum
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.334 $0.246
▲ Up 15% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense Nicotine 4 mg 00113-0053-06 L. 1 gum $0.282 — Availability likely —
Good Sense Nicotine 4 mg 00113-0422-25 L. 1 gum $0.282 — Discontinued —
Good Sense Nicotine 4 mg 00113-0532-60 L. 1 gum $0.282 — Availability likely —
good sense nicotine 4 mg 00113-8600-25 L. 1 gum $0.282 — Availability likely —
Nicotine 4 mg 00536-1372-06 Rugby 10 gums $0.282 — Discontinued —
Nicotine 4 mg 00536-3030-06 Rugby 10 gums $0.282 — Availability likely —
Nicotine 4 mg 00536-3113-01 Rugby 10 gums $0.282 — Discontinued —
Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor 4 mg 00536-3387-01 Rugby 10 gums $0.282 — Discontinued —
Nicotine 4 mg 00536-3405-01 Rugby 1 gum $0.282 — Discontinued —
Nicotine 4 mg 45802-0651-25 Padagis 1 gum $0.282 — Availability likely —
Nicotine Polacrilex coated ice mint 4 mg 46122-0449-58 AmerisourceBergen 1 gum $0.282 — Availability likely —
Nicotine Polacrilex 4 mg 46122-0718-60 AmerisourceBergen 1 gum $0.282 — Availability likely —
Nicotine Polacrilex 4 mg 46122-0720-25 AmerisourceBergen 1 gum $0.282 — Availability likely —
Nicotine Polacrilex 4 mg 46122-0725-71 AmerisourceBergen 1 gum $0.282 — Availability likely —
Nicotine 4 mg 46122-0733-60 AmerisourceBergen 1 gum $0.282 — Availability likely —
Nicotine Polacrilex 4 mg 57237-0323-01 Rising 10 gums $0.282 — Availability likely —
Nicotine 4 mg 63739-0369-10 McKesson 1 gum $0.282 — Discontinued —
Nicotine Polacrilex Original 4 mg 70000-0341-01 CARDINAL 1 gum $0.282 — Availability likely —
Nicotine Polacrilex Coated Fruit 4 mg 70000-0342-01 CARDINAL 1 gum $0.282 — Availability likely —
Nicotine Polacrilex Coated Mint 4 mg 70000-0343-01 CARDINAL 1 gum $0.282 — Availability likely —
Nicotine Polacrilex Coated Ice Mint 4 mg 70000-0344-01 CARDINAL 1 gum $0.282 — Availability likely —
foster and thrive nicotine 4 mg 70677-1165-01 Strategic 1 gum $0.282 — Availability likely —
foster and thrive nicotine 4 mg 70677-1167-01 Strategic 1 gum $0.282 — Availability likely —
Foster and Thrive Nicotine 4 mg 70677-1171-01 Strategic 1 gum $0.282 — Availability likely —
foster and thrive nicotine 4 mg 70677-1193-01 Strategic 1 gum $0.282 — Availability likely —
good neighbor pharmacy nicotine 4 mgthis 46122-0666-78 Amerisource 1 gum $0.282 — Discontinued —
Good Sense Nicotine 4 mg 00113-0170-25 L. 1 gum $0.313 — Discontinued +11%
Good Sense Nicotine 4 mg 00113-0854-60 L. 1 gum — — Discontinued —
Good Sense Nicotine 4 mg 00113-4111-06 L. 1 gum — — FDA listed —
Nicorette Original 4 mg 00135-0158-07 Haleon 110 gums — — FDA listed —
Nicorette Mint 4 mg 00135-0230-03 Haleon 50 gums — — FDA listed —
Nicorette Fruit Chill 4 mg 00135-0242-02 Haleon 100 gums — — FDA listed —
Nicorette Spearmint Burst 4 mg 00135-0355-03 Haleon 10 gums — — FDA listed —
Nicorette Cinnamon Surge 4 mg 00135-0467-01 Haleon 20 gums — — FDA listed —
Nicorette White Ice Mint 4 mg 00135-0475-01 Haleon 20 gums — — FDA listed —
Nicorette Spearmint Burst 4 mg 00135-0533-02 Haleon 10 gums — — FDA listed —
Nicotine 4 mg 00363-0919-06 Walgreen 1 gum — — FDA listed —
Nicotine Polacrilex MINT 4 mg 00363-1421-98 Walgreens 1 gum — — FDA listed —
Nicotine Polacrilex original 4 mg 00363-1609-62 Walgreens 1 gum — — FDA listed —
nicotine 4 mg 00363-2309-78 Walgreen 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 00363-3290-10 Walgreens 1 gum — — FDA listed —
Nicotine 4 mg 00363-3911-10 Walgreens 1 gum — — FDA listed —
nicotine 4 mg 00363-7103-06 Walgreen 1 gum — — FDA listed —
nicotine 4 mg 00363-7971-06 Walgreen 1 gum — — FDA listed —
Nicotine 4 mg 00363-9310-10 Walgreens 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 00363-9330-10 Walgreens 1 gum — — FDA listed —
Nicotine 4 mg 00363-9350-30 Walgreens 1 gum — — FDA listed —
nicotine 4 mg 11822-0170-01 Rite 1 gum — — FDA listed —
nicotine 4 mg 11822-0309-00 Rite 1 gum — — Discontinued —
Nicotine 4 mg 11822-0699-01 Rite 1 gum — — FDA listed —
nicotine 4 mg 11822-0971-01 Rite 1 gum — — FDA listed —
nicotine 4 mg 11822-1103-00 Rite 1 gum — — FDA listed —
Rugby Nicotine Polacrilex Gum, Original Flavor 4 mg 17856-3030-01 ATLANTIC 1 gum — — FDA listed —
signature care nicotine 4 mg 21130-0173-78 Safeway 1 gum — — FDA listed —
signature care nicotine 4 mg 21130-0522-25 Safeway 1 gum — — FDA listed —
signature care nicotine 4 mg 21130-0820-78 Safeway 1 gum — — FDA listed —
Nicorette Fruit Chill nicotine polacrilex 4 mg 29485-5270-01 Lil' 10 gums — — FDA listed —
Nicorette White Mint nicotine polacrilex 4 mg 29485-5271-01 Lil' 10 gums — — FDA listed —
Nicotine 4 mg 30142-0309-06 Kroger 1 gum — — FDA listed —
Nicotine 4 mg 30142-0671-11 The 1 gum — — FDA listed —
nicotine 4 mg 30142-0848-06 Kroger 1 gum — — FDA listed —
Topcare Nicotine 4 mg 36800-0170-25 Topco 1 gum — — FDA listed —
Topcare Nicotine 4 mg 36800-0532-60 Topco 1 gum — — FDA listed —
Topcare Nicotine 4 mg 36800-0650-60 Topco 1 gum — — FDA listed —
topcare nicotine 4 mg 36800-0967-78 Topco 1 gum — — FDA listed —
nicotine 4 mg 37808-0611-96 H 1 gum — — FDA listed —
Nicotine 4 mg 37808-0658-06 H 1 gum — — FDA listed —
nicotine 4 mg 37808-0683-06 H 1 gum — — FDA listed —
nicotine 4 mg 37808-0739-06 H 1 gum — — FDA listed —
Nicotine 4 mg 37808-0821-16 H 1 gum — — FDA listed —
nicotine 4 mg 37808-0849-60 H 1 gum — — FDA listed —
Nicotine 4 mg 41250-0170-29 Meijer 1 gum — — FDA listed —
Nicotine 4 mg 41250-0510-06 Meijer 1 gum — — FDA listed —
Nicotine 4 mg 41250-0532-06 Meijer 1 gum — — FDA listed —
nicotine 4 mg 41250-0689-06 Meijer 1 gum — — FDA listed —
Nicotine 4 mg 41250-0854-06 Meijer 1 gum — — Discontinued —
careone nicotine 4 mg 41520-0843-60 American 1 gum — — FDA listed —
Care One Nicotine 4 mg 41520-0854-78 American 1 gum — — FDA listed —
careone nicotine 4 mg 41520-0891-25 American 1 gum — — FDA listed —
nicotine 4 mg 42507-0309-78 HyVee 1 gum — — FDA listed —
Equate nicotine 4 mg 49035-0170-29 Wal-Mart 1 gum — — FDA listed —
equate nicotine 4 mg 49035-0309-78 Wal-Mart 1 gum — — FDA listed —
equate nicotine 4 mg 49035-0422-96 Wal-Mart 1 gum — — FDA listed —
equate Nicotine 4 mg 49035-0442-06 Wal-Mart 1 gum — — FDA listed —
Equate nicotine 4 mg 49035-0532-06 Wal-Mart 1 gum — — Discontinued —
Equate Nicotine 4 mg 49035-0854-06 Wal-Mart 1 gum — — FDA listed —
Good Sense 4 mg 50090-6240-00 A-S 1 gum — — FDA listed —
Nicotine 4 mg 50090-6674-00 A-S 110 gums — — FDA listed —
good sense nicotine 4 mg 50090-6695-00 A-S 1 gum — — FDA listed —
Nicotine 4 mg 51316-0309-10 CVS 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 55301-0429-44 AAFES/Your 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 55301-0504-44 AAFES/Your 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 55319-0966-20 Family 1 gum — — FDA listed —
Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon 55741-0001-10 Dr. 10 gums — — FDA listed —
dg health nicotine 4 mg 55910-0122-58 Dolgencorp 1 gum — — FDA listed —
Rexall Nicotine 4 mg 55910-0532-60 Dolgencorp, 1 gum — — Discontinued —
Nicotine Polacrilex 4 mg 55910-0796-20 Dolgencorp, 1 gum — — FDA listed —
Nicotine 4 mg 55910-0918-20 Dolgencorp, 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 55910-0933-10 Dolgencorp, 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 55910-0976-20 Dolgencorp, 1 gum — — FDA listed —
Coated Nicotine 4 mg 56062-0369-60 Publix 1 gum — — FDA listed —
Nicotine Polacrilex Coated Mint 4 mg 56062-0429-44 Publix 10 gums — — FDA listed —
Nicotine Polacrilex Coated Fruit 4 mg 56062-0504-44 Publix 10 gums — — FDA listed —
Nicotine Polacrilex Origianl Flavor 4 mg 56062-0609-62 Publix 10 gums — — FDA listed —
Nicotine 4 mg 59726-0913-16 P 1 gum — — FDA listed —
Nicotine 4 mg 59726-0935-17 P 1 gum — — FDA listed —
Nicotine Polacrilex Gum 4 mg 63443-5057-01 Fertin 10 gums — — FDA listed —
kirkland signature quit 4 4 mg 63981-0170-01 Costco 1 gum — — FDA listed —
kirkland signature quit 4 4 mg 63981-0309-47 Costco 1 gum — — FDA listed —
Nicorette 4mg Cinnamon Surge 4 mg 66715-8123-00 Lil' 10 gums — — FDA listed —
Nicorette 4mg Fruit Chill Gum, Lil Drug Store 4 mg 66715-8124-00 Lil' 10 gums — — FDA listed —
Nicorette 4mg White Ice Mint Gum, Lil Drug Store 4 mg 66715-8125-00 Lil' 10 gums — — FDA listed —
Nicotine Polacrilex Coated Mint 4 mg 68016-0281-49 Chain 10 gums — — FDA listed —
Nicotine Polacrilex Coated Mint 4 mg 68016-0285-44 Chain 10 gums — — FDA listed —
Nicotine Polacrilex, Original 4 mg 68016-0287-62 Chain 10 gums — — FDA listed —
Nicotine Polacrilex 4 mg 68016-0293-44 Chain 1 gum — — FDA listed —
Nicotine Polacrilex Coated Mint 4 mg 68016-0560-00 Chain 10 gums — — FDA listed —
members mark nicotine 4 mg 68196-0170-01 Sam's 1 gum — — FDA listed —
members mark nicotine 4 mg 68196-0309-47 Sam's 1 gum — — FDA listed —
Members Mark Nicotine 4 mg 68196-0971-47 Sam's 1 gum — — FDA listed —
berkley and jensen nicotine 4 mg 68391-0170-06 BJWC 1 gum — — FDA listed —
Berkley and Jensen Nicotine 4 mg 68391-0309-25 BJWC 1 gum — — Discontinued —
Nicotine Polacrilex coated fruit 4 mg 69842-0025-15 CVS 1 gum — — FDA listed —
Nicotine Polacrilex coated cinnamon 4 mg 69842-0028-44 CVS 1 gum — — FDA listed —
Nicotine Polacrilex coated ice mint 4 mg 69842-0217-15 CVS 1 gum — — FDA listed —
Nicotine Polacrilex coated mint 4 mg 69842-0430-16 CVS 1 gum — — FDA listed —
Nicotine Polacrilex original 4 mg 69842-0609-15 CVS 1 gum — — FDA listed —
Nicotine 4 mg 72224-0930-10 Lucy 1 gum — — FDA listed —
Nicotine 4 mg 72224-0931-10 Lucy 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 72224-0933-10 Lucy 1 gum — — FDA listed —
Basic Care Nicotine 4 mg 72288-0003-06 Amazon.com 1 gum — — FDA listed —
basic care nicotine 4 mg 72288-0170-02 Amazon.com 1 gum — — FDA listed —
basic care nicotine 4 mg 72288-0442-06 Amazon.com 1 gum — — FDA listed —
basic care nicotine 4 mg 72288-0532-06 Amazon.com 1 gum — — FDA listed —
basic care nicotine 4 mg 72288-0577-06 Amazon.com 1 gum — — FDA listed —
basic care nicotine 4 mg 72288-0693-01 Amazon.com 1 gum — — FDA listed —
Habitrol Nicotine Polacrilex Gum 4 mg Coated Fruit 75907-0300-10 Dr. 10 gums — — FDA listed —
Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint 75907-0303-10 Dr. 10 gums — — FDA listed —
nicotine 4 mg 79481-0103-00 Meijer, 1 capsule — — FDA listed —
nicotine 4 mg 79481-0601-00 Meijer, 1 gum — — FDA listed —
up and up uncoated original nicotine 4 mg 82442-0170-02 Target 1 gum — — FDA listed —
Up And Up Coated Cinnamon Nicotine 4 mg 82442-0329-06 Target 1 gum — — FDA listed —
Up and Up Mint Nicotine 4 mg 82442-0500-96 Target 1 gum — — FDA listed —
Up and Up Nicotine 4 mg 82442-0532-78 Target 1 gum — — FDA listed —
up and up coated mint freeze nicotine 4 mg 82442-0723-06 Target 1 gum — — FDA listed —
Up And Up Coated Fruit Nicotine 4 mg 82442-0971-06 Target 1 gum — — FDA listed —
Blip 4 mg 82966-0309-60 Blip 1 gum — — FDA listed —
blip 4 mg 82966-0971-60 Blip 1 gum — — FDA listed —
quitine nicotine 4 mg 84720-0532-70 QUITINE 1 gum — — FDA listed —
quitine nicotine 4 mg 84720-0854-70 QUITINE 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 84720-0933-03 Quitine 1 gum — — FDA listed —
Oneoo Nicotine Gum (Mint) 4 mg 87494-0003-01 Guangzhou 60 gums — — FDA listed —
Oneoo Nicotine Gum (Grape) 4 mg 87494-0004-01 Guangzhou 60 gums — — FDA listed —
Oneoo Nicotine Gum (3 Flavors) 4 mg 87494-0006-01 Guangzhou 1 gum — — FDA listed —
Oneoo Nicotine Gum (Cinnamon) 4 mg 87494-0007-01 Guangzhou 60 gums — — Discontinued —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
46122-0666-78 You're viewing this 100 BLISTER PACK in 1 CARTON (46122-666-78) / 1 GUM, CHEWING in 1 BLISTER PACK 2020-10-08 Discontinued by firm

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA.
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 46122-666-78, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 46122-0666-78, written without dashes as 46122066678. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 46122-0666-78, the first segment (46122) is the labeler code FDA assigned to Amerisource Bergen; the middle segment (0666) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (78) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Amerisource Bergen is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
← 46122-0660-62 · AMERISOURCE 46122-0669-78 · AmerisourceBergen →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.