BENZOCAINE and RESORCINOL

Product NDC
67868-117
11-digit product format
678680117
Labeler code
67868
Product ID
67868-117_d1f9eabc-99ec-4daa-a999-47aaca7d1aa0
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOCAINE and RESORCINOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Pharma Pac, LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-05-19
Marketing end
0000-00-00
Substance
BENZOCAINE; RESORCINOL
Active strength
200 mg/g; mg/g
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 productproduct67868-117IInactivated by FDA2026-08-11
excluded packagepackage67868-11767868-117-90IInactivated by FDA2026-08-11

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 packagepackage67868-117-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67868-117-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67868-117-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67868-117-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67868-117-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67868-117-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67868-117-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67868-117-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67868-117-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67868-117-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67868-117-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67868-117-90557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67868-117-908af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67868-117-90834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67868-117-901332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67868-117-90fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67868-117-9086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67868-117-90bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage67868-117-908dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage67868-117-90e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage67868-117-909bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67868-117-90110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67868-117-902019-10-29C16284748780-1960f7f55-c551-8e05-e053-dbdaa90a074adrug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67868-117-90BENZOCAINE and RESORCINOL28 g in 1 TUBECREAM287

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5BENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
RESORCINOLACTIVE INGREDIENTYUL4LO94HKBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
BENZOCAINEACTIVE MOIETYU3RSY48JW5BENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
RESORCINOLACTIVE MOIETYYUL4LO94HKBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1BENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
CORN OILINACTIVE INGREDIENT8470G57WFMBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4BENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
ISOPROPYL STEARATEINACTIVE INGREDIENT43253ZW1MZBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
POLYOXYL 100 STEARATEINACTIVE INGREDIENTYD01N1999RBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
TRISODIUM HEDTAINACTIVE INGREDIENTK3E0U7O8KIBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
VITAMIN AINACTIVE INGREDIENT81G40H8B0TBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
VITAMIN DINACTIVE INGREDIENT9VU1KI44GPBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
WATERINACTIVE INGREDIENT059QF0KO0RBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67868-117BENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7Legacy NDC, 1 package rows20110719_6cf1ab7b-8d16-4d41-a3bb-92ba603d3f7e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
67868-117-906786801179028 g in 1 TUBE28 gHistorical