Preparing Tonic

Product NDC
51830-054
11-digit product format
518300054
Labeler code
51830
Product ID
51830-054_23c8b813-23a3-4a5b-bad3-e3a7d8d19896
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
LOTION
Route
TOPICAL
Labeler
Lange SAS
Application
part333D
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-07-18
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
2 mg/180mg
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 productproduct51830-054IInactivated by FDA2026-10-05
excluded packagepackage51830-05451830-054-07IInactivated 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 packagepackage51830-054-07d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51830-054-07f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51830-054-072ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51830-054-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51830-054-07cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51830-054-07cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51830-054-07302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51830-054-07ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51830-054-070efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51830-054-07ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51830-054-07367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51830-054-07557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51830-054-078af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51830-054-07834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51830-054-071332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51830-054-07fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51830-054-0786f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51830-054-07bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51830-054-078dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51830-054-07e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51830-054-079bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51830-054-07110d247fa046…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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51830-054-072019-11-27C16284748780-19855d018-e750-cd31-e053-dbdaa90ab51a92a7f3ba-ac9b-41d9-bcd7-1a45d0b1782d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51830-054-07Preparing Tonic180 mg in 1 BOXLOTION1802

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
ALLANTOININACTIVE INGREDIENT344S277G0ZPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8PREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
ETHYLPARABENINACTIVE INGREDIENT14255EXE39PREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
IMIDUREAINACTIVE INGREDIENTM629807ATLPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9OPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
MAGNESIUM NITRATEINACTIVE INGREDIENT77CBG3UN78PREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
METHYLPARABEN SODIUMINACTIVE INGREDIENTCR6K9C2NHKPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QTPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
SORBITOLINACTIVE INGREDIENT506T60A25RPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
TRIETHYLENE GLYCOLINACTIVE INGREDIENT3P5SU53360PREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
URTICA DIOICA LEAFINACTIVE INGREDIENTX6M0DRN46QPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
WATERINACTIVE INGREDIENT059QF0KO0RPREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2
ZINC PIDOLATEINACTIVE INGREDIENTC32PQ86DH4PREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51830-054PREPARING TONIC (SALICYLIC ACID) LOTION [LANGE SAS]2Legacy NDC, 1 package rows20130213_92a7f3ba-ac9b-41d9-bcd7-1a45d0b1782d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245199salicylic acid 1 % Topical LotionPSN92a7f3ba-ac9b-41d9-bcd7-1a45d0b1782d2
245199salicylic acid 10 MG/ML Topical LotionSCD92a7f3ba-ac9b-41d9-bcd7-1a45d0b1782d2
245199salicylic acid 1 % Topical LotionSY92a7f3ba-ac9b-41d9-bcd7-1a45d0b1782d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
51830-054-0751830005407180 mg in 1 BOX180 mgHistorical