FDA.reportPublic FDA data

Nicotine Polacrilex

Product NDC
43598-486
11-digit product format
435980486
Labeler code
43598
Product ID
43598-486_33e2c1b3-2ea4-98f4-47c2-320c8ddd608e
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA212796
Marketing category
ANDA
Marketing start
2020-06-09
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
unfinished productproduct43598-486UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage43598-48643598-486-99UNFINISHEDActive or certified unfinished drug listing2026-08-17

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 · 32 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 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage43598-486-99a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage43598-486-991d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage43598-486-99390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage43598-486-99e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage43598-486-99bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage43598-486-99f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage43598-486-99f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage43598-486-9968b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage43598-486-9905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage43598-486-9948b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage43598-486-9927f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage43598-486-998d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage43598-486-99d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage43598-486-9950b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage43598-486-99906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage43598-486-996db9cb8d1e19…3449e1ec5b70…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212796-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08
A212796-002NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-084b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212796-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2020-01-08782e0a99824c…
2021-12-28 21:50 UTC2021-12A212796-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2020-01-08782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Polacrilex
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6M3C89ZY6RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
359817Internal RxNorm lookup
359818Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b0fdb36d-4cf5-8a91-3da1-90e3587450f9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
43598-486-102024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-102024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-122024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-122024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-132024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-132024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-142024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-142024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-162024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-162024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-172024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-172024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-182024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-182024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-192024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-192024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-222024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-222024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-232024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-232024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-242024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-242024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-272024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-272024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-292024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-292024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-482024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-482024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-542024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-542024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-722024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-722024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-732024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-732024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-742024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-742024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-812024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-812024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-962024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-962024-01-30c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-992021-12-10c7ccaba7-2877-fd44-e053-dadaa90aa01bNicotine Polacrilex Lozenge 2 mg Mint
43598-486-102021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-102021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-122021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-122021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-132021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-132021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-142021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-142021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-162021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-162021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-172021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-172021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-182021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-182021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-192021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-192021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-222021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-222021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-232021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-232021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-242021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-242021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-272021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-272021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-292021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-292021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-482021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-482021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-542021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-542021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-722021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-722021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-732021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-732021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-742021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-742021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-812021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-812021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-962021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-962021-12-09c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-102021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-102021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-122021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-122021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-132021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-132021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-142021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-142021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-162021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-162021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-172021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-172021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-182021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-182021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-192021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-192021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-222021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-222021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-232021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-232021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-242021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-242021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-272021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-272021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-292021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-292021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-482021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-482021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-542021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-542021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-722021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-722021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-732021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-732021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-742021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-742021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-812021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-812021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-486-962021-07-23c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-486-10EA - Each43598-486cdb14909-dfb6-4e9e-8223-eef4a08f2b0812020-07-13
43598-486-24EA - Each43598-48673ea51e6-d170-4b75-b564-7809a20564dc12020-07-13
43598-486-27EA - Each43598-4861fe813f2-bac9-4f63-bf25-12cb27ad785712020-07-13
43598-486-72EA - Each43598-48621732bd1-6693-4222-ba9c-02f78a087bb512020-07-13
43598-486-81EA - Each43598-48667c14cac-e115-43b5-896f-f4707cac872112020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-486NICOTINE POLACRILEX LOZENGE [DR. REDDY'S LABORATORIES INC.]7Current NDC, Legacy NDC20240706_b0fdb36d-4cf5-8a91-3da1-90e3587450f9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Habitrol Nicotine Polacrilex Lozenge MintNICOTINE POLACRILEX LOZENGE 2 MGDr. Reddy's Laboratories Inc.836bae74-076b-3c92-dee9-22b8519b529d2026-07-09WarningsExact identifier
application applno (ANDA): 212796
application number: ANDA212796
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.b0fdb36d-4cf5-8a91-3da1-90e3587450f92026-07-09WarningsExact identifier
application applno (ANDA): 212796
application number: ANDA212796
ndc (product): 43598-486
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepackb2f4506b-b575-4ed8-b10b-935451ea34512025-08-26WarningsExact identifier
application applno (ANDA): 212796
application number: ANDA212796
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepacka3ca2479-9703-41de-918a-881da16e5c982025-08-26WarningsExact identifier
application applno (ANDA): 212796
application number: ANDA212796

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNb2f4506b-b575-4ed8-b10b-935451ea3451103
359817nicotine 2 MG Oral LozengeSCDb2f4506b-b575-4ed8-b10b-935451ea3451103
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYb2f4506b-b575-4ed8-b10b-935451ea3451103
359817nicotine 2 MG TrocheSYb2f4506b-b575-4ed8-b10b-935451ea3451103
359817nicotine 2 MG Oral LozengePSNb0fdb36d-4cf5-8a91-3da1-90e3587450f98
359818nicotine 4 MG Oral LozengePSNb0fdb36d-4cf5-8a91-3da1-90e3587450f98
359817nicotine 2 MG Oral LozengeSCDb0fdb36d-4cf5-8a91-3da1-90e3587450f98
359818nicotine 4 MG Oral LozengeSCDb0fdb36d-4cf5-8a91-3da1-90e3587450f98
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYb0fdb36d-4cf5-8a91-3da1-90e3587450f98
359817nicotine 2 MG TrocheSYb0fdb36d-4cf5-8a91-3da1-90e3587450f98
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYb0fdb36d-4cf5-8a91-3da1-90e3587450f98
359818nicotine 4 MG TrocheSYb0fdb36d-4cf5-8a91-3da1-90e3587450f98
2548896Habitrol 2 MG Oral LozengePSN836bae74-076b-3c92-dee9-22b8519b529d5
2548898Habitrol 4 MG Oral LozengePSN836bae74-076b-3c92-dee9-22b8519b529d5
359817nicotine 2 MG Oral LozengePSN836bae74-076b-3c92-dee9-22b8519b529d5
359818nicotine 4 MG Oral LozengePSN836bae74-076b-3c92-dee9-22b8519b529d5
2548896nicotine 2 MG Oral Lozenge [Habitrol]SBD836bae74-076b-3c92-dee9-22b8519b529d5
2548898nicotine 4 MG Oral Lozenge [Habitrol]SBD836bae74-076b-3c92-dee9-22b8519b529d5
359817nicotine 2 MG Oral LozengeSCD836bae74-076b-3c92-dee9-22b8519b529d5
359818nicotine 4 MG Oral LozengeSCD836bae74-076b-3c92-dee9-22b8519b529d5
2548896Habitrol 2 MG Oral LozengeSY836bae74-076b-3c92-dee9-22b8519b529d5
2548898Habitrol 4 MG Oral LozengeSY836bae74-076b-3c92-dee9-22b8519b529d5
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY836bae74-076b-3c92-dee9-22b8519b529d5
359817nicotine 2 MG TrocheSY836bae74-076b-3c92-dee9-22b8519b529d5
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY836bae74-076b-3c92-dee9-22b8519b529d5
359818nicotine 4 MG TrocheSY836bae74-076b-3c92-dee9-22b8519b529d5
359817nicotine 2 MG Oral LozengePSNe0234492-d92d-ee93-493f-1099d45447224
359818nicotine 4 MG Oral LozengePSNe0234492-d92d-ee93-493f-1099d45447224
359817nicotine 2 MG Oral LozengeSCDe0234492-d92d-ee93-493f-1099d45447224
359818nicotine 4 MG Oral LozengeSCDe0234492-d92d-ee93-493f-1099d45447224
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYe0234492-d92d-ee93-493f-1099d45447224
359817nicotine 2 MG TrocheSYe0234492-d92d-ee93-493f-1099d45447224
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYe0234492-d92d-ee93-493f-1099d45447224
359818nicotine 4 MG TrocheSYe0234492-d92d-ee93-493f-1099d45447224

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-486-10435980486104 BOTTLE in 1 CARTON (43598-486-10) / 27 LOZENGE in 1 BOTTLE4 bottle2020-06-090000-00-00NoNoCurrent
43598-486-12435980486125 BOTTLE in 1 CARTON (43598-486-12) / 24 LOZENGE in 1 BOTTLE5 bottle2020-06-090000-00-00NoNoCurrent
43598-486-13435980486135 BOTTLE in 1 CARTON (43598-486-13) / 27 LOZENGE in 1 BOTTLE5 bottle2020-06-090000-00-00NoNoCurrent
43598-486-14435980486146 BOTTLE in 1 CARTON (43598-486-14) / 24 LOZENGE in 1 BOTTLE6 bottle2020-06-090000-00-00NoNoCurrent
43598-486-16435980486166 BOTTLE in 1 CARTON (43598-486-16) / 27 LOZENGE in 1 BOTTLE6 bottle2020-06-090000-00-00NoNoCurrent
43598-486-17435980486177 BOTTLE in 1 CARTON (43598-486-17) / 24 LOZENGE in 1 BOTTLE7 bottle2020-06-090000-00-00NoNoCurrent
43598-486-18435980486187 BOTTLE in 1 CARTON (43598-486-18) / 27 LOZENGE in 1 BOTTLE7 bottle2020-06-090000-00-00NoNoCurrent
43598-486-19435980486198 BOTTLE in 1 CARTON (43598-486-19) / 24 LOZENGE in 1 BOTTLE8 bottle2020-06-090000-00-00NoNoCurrent
43598-486-224359804862210 BOTTLE in 1 CARTON (43598-486-22) / 24 LOZENGE in 1 BOTTLE10 bottle2020-06-090000-00-00NoNoCurrent
43598-486-23435980486238 BOTTLE in 1 CARTON (43598-486-23) / 27 LOZENGE in 1 BOTTLE8 bottle2020-06-090000-00-00NoNoCurrent
43598-486-24435980486241 BOTTLE in 1 CARTON (43598-486-24) / 24 LOZENGE in 1 BOTTLE1 bottle2020-06-090000-00-00NoNoCurrent
43598-486-27435980486271 BOTTLE in 1 CARTON (43598-486-27) / 27 LOZENGE in 1 BOTTLE1 bottle2020-06-090000-00-00NoNoCurrent
43598-486-294359804862910 BOTTLE in 1 CARTON (43598-486-29) / 27 LOZENGE in 1 BOTTLE10 bottle2020-06-090000-00-00NoNoCurrent
43598-486-48435980486482 BOTTLE in 1 CARTON (43598-486-48) / 24 LOZENGE in 1 BOTTLE2 bottle2020-06-090000-00-00NoNoCurrent
43598-486-54435980486542 BOTTLE in 1 CARTON (43598-486-54) / 27 LOZENGE in 1 BOTTLE2 bottle2020-06-090000-00-00NoNoCurrent
43598-486-72435980486723 BOTTLE in 1 CARTON (43598-486-72) / 24 LOZENGE in 1 BOTTLE3 bottle2020-06-090000-00-00NoNoCurrent
43598-486-73435980486737 BOTTLE in 1 CARTON (43598-486-73) / 24 LOZENGE in 1 BOTTLE7 bottle2020-06-090000-00-00NoNoCurrent
43598-486-74435980486747 BOTTLE in 1 CARTON (43598-486-74) / 27 LOZENGE in 1 BOTTLE7 bottle2020-06-090000-00-00NoNoCurrent
43598-486-81435980486813 BOTTLE in 1 CARTON (43598-486-81) / 27 LOZENGE in 1 BOTTLE3 bottle2020-06-090000-00-00NoNoCurrent
43598-486-96435980486964 BOTTLE in 1 CARTON (43598-486-96) / 24 LOZENGE in 1 BOTTLE4 bottle2020-06-090000-00-00NoNoCurrent
43598-486-99435980486998333 LOZENGE in 1 POUCH (43598-486-99)8333 lozenge08-JAN-20Current