LIDOCAINE

Product NDC
82927-001
11-digit product format
829270001
Labeler code
82927
Product ID
82927-001_e32f1a47-9a5c-73de-e053-2995a90a28a4
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE
Dosage form
CREAM
Route
TOPICAL
Labeler
CHENGDU DISCOUNT TRADING CO.LTD
Application
M015
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-08-08
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
5 g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct82927-001IInactivated by FDA2026-10-21
excluded packagepackage82927-00182927-001-01IInactivated by FDA2026-10-21

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 · 30 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 packagepackage82927-001-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage82927-001-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage82927-001-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage82927-001-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage82927-001-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage82927-001-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage82927-001-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage82927-001-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage82927-001-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage82927-001-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage82927-001-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage82927-001-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage82927-001-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage82927-001-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage82927-001-011332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82927-001-012023-07-28C16284748780-10191ceaa-6516-198a-e063-dbdaa90aec3e001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82927-001-01LIDOCAINE56 g in 1 BOXCREAM561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82927-001LIDOCAINE CREAM [CHENGDU DISCOUNT TRADING CO.LTD]1Legacy NDC, 1 package rows20220813_e32f1a47-9a5b-73de-e053-2995a90a28a4.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 15 of 22 · 436 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBionpharma Inc.1790da99-2a22-e2a2-e063-6394a90ac36f2025-03-31WarningsExact identifier
application number: M015
HemAwayLIDOCAINEMelaleuca, Inc.cf842adf-fcd7-2c8c-e053-2995a90adea62025-03-27WarningsExact identifier
application number: M015
Numb and Number Anorectal CreamLIDOCAINEDermtech Labs, Inc31420635-5021-173d-e063-6294a90a407a2025-03-26WarningsExact identifier
application number: M015
Leader Maximum Strength Hemorrhoidal ReliefLIDOCAINECardinal Health,Inc.65c780b0-7f47-4ae9-a847-c22deaaa28882025-03-21WarningsExact identifier
application number: M015
Curist Hemorrhoid Fissure ReliefLIDOCAINELittle Pharma, Inc2fb02b00-acdb-5184-e063-6294a90ae1c82025-03-06WarningsExact identifier
application number: M015
Thera Plus HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEFOURSTAR GROUP USA, INC.87143a7a-7b2d-4b67-afda-2355697e73002025-03-04WarningsExact identifier
application number: M015
Numbskin Maximum Strength Pain RelieverLIDOCAINEShinpharma Inc2f288bde-99fd-42f8-e063-6394a90a0f052025-02-27WarningsExact identifier
application number: M015
PREPARATION H TOTABLES IRRITATION RELIEF WIPESWITCH HAZELHaleon US Holdings LLC1953ec64-20ce-488b-8f14-44e15cc9e7202025-02-21WarningsExact identifier
application number: M015
LBRI STOP THE PAIN Super Aloe Pain Relief CreamMENTHOL, METHYL SALICYLATEL'BRI HEALTH AND BEAUTY INC62e18a37-c0db-4b1e-a6a1-35684cc00e082025-01-28WarningsExact identifier
application number: M015
HemorrhoidalPAIN RELIEFNeilMed Pharmaceuticals Inc.038a2cf5-1b72-227b-e063-6394a90a84ad2025-01-24WarningsExact identifier
application number: M015
lidocaineLIDOCAINENivagen Pharmaceuticals, Inc.32964ec3-1880-477b-9f71-2222c39106aa2025-01-23WarningsExact identifier
application number: M015
Hemorrhoidal cocoa butterHEMORRHOIDALNeilMed Pharmaceuticals Inc.03b159b0-b960-b38d-e063-6394a90a94622025-01-17WarningsExact identifier
application number: M015
Gentle Laxative BisacodylGENTLE LAXATIVE BISACODYLNeilMed Pharmaceuticals Inc03b3733a-4d78-149f-e063-6294a90a65182025-01-17WarningsExact identifier
application number: M015
Glycerin LaxativeGLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEFNeilMed Pharmaceuticals Inc.03b4be69-6488-76be-e063-6394a90a7edf2025-01-17WarningsExact identifier
application number: M015
Pre-moistened Medicated Wipes, Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal Astringent, Walgreens Pre-moistened Medicated Wipes, Walgreens Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal AstringentWITCH HAZELWalgreens Company209a111b-d169-cb5d-e063-6394a90a33ca2025-01-15WarningsExact identifier
application number: M015
Pre-moistened Medicated Pads, Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch Hazel, Walgreens Pre-moistened Medicated Pads, Walgreens Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch HazelWITCH HAZELWalgreens Company1e2dcec1-a1fe-71d2-e063-6394a90a99082025-01-15WarningsExact identifier
application number: M015
AER Pre-moistened Witch Hazel PadWITCH HAZELBirchwood Laboratories LLC1cca622f-0a6b-4f35-9355-34c249ee705e2025-01-14WarningsExact identifier
application number: M015
B-SURE Traveler ToweletteB-SURE TRAVELERBirchwood Laboratories LLCe1a5da94-6a1a-497b-a737-1c1541bf04042025-01-14WarningsExact identifier
application number: M015
CalmoseptineANORECTAL OINTMENTCalmoseptine Inc.ff9539ed-d9ae-401d-adbc-df8f1d7514312025-01-13WarningsExact identifier
application number: M015
DibucaineDIBUCAINEAkron Pharma Inc.60469e43-ab6f-46d3-a1df-00e58275f5652025-01-12WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1534792lidocaine 5 % Topical CreamPSNe32f1a47-9a5b-73de-e053-2995a90a28a41
1534792lidocaine 50 MG/ML Topical CreamSCDe32f1a47-9a5b-73de-e053-2995a90a28a41
1534792lidocaine 5 % Topical CreamSYe32f1a47-9a5b-73de-e053-2995a90a28a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82927-001-018292700010156 g in 1 BOX (82927-001-01) 56 g2022-08-080000-00-00NoNoCurrent