Kendall Soothing

Product NDC
28851-695
11-digit product format
288510695
Labeler code
28851
Product ID
28851-695_472d414c-1970-415f-b1ab-85bd657d6e74
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Covidien Inc.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-04-22
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
10 mL/100mL
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct28851-695IInactivated by FDA2026-09-14
excluded packagepackage28851-69528851-695-01IInactivated by FDA2026-09-14
excluded packagepackage28851-69528851-695-02IInactivated by FDA2026-09-14
excluded packagepackage28851-69528851-695-03IInactivated by FDA2026-09-14

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 2 · 88 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 packagepackage28851-695-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage28851-695-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage28851-695-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage28851-695-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage28851-695-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage28851-695-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage28851-695-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage28851-695-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage28851-695-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage28851-695-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage28851-695-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage28851-695-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage28851-695-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage28851-695-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage28851-695-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage28851-695-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage28851-695-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage28851-695-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage28851-695-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage28851-695-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage28851-695-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage28851-695-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage28851-695-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage28851-695-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage28851-695-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage28851-695-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage28851-695-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage28851-695-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage28851-695-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage28851-695-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage28851-695-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage28851-695-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage28851-695-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage28851-695-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage28851-695-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage28851-695-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage28851-695-038af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage28851-695-028af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage28851-695-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage28851-695-03834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage28851-695-02834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage28851-695-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage28851-695-031332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage28851-695-021332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage28851-695-011332a3947898…d4bfe170f9cd…

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
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
28851-695-012019-10-29C16284748780-1960f7f55-ca85-8e05-e053-dbdaa90a074aKendall Soothing Ointment
28851-695-022019-10-29C16284748780-1960f7f55-ca85-8e05-e053-dbdaa90a074aKendall Soothing Ointment
28851-695-032019-10-29C16284748780-1960f7f55-ca85-8e05-e053-dbdaa90a074aKendall Soothing Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
28851-695-01Kendall Soothing59 mL in 1 TUBEOINTMENT592
28851-695-02Kendall Soothing118 mL in 1 TUBEOINTMENT1182
28851-695-03Kendall Soothing4 mL in 1 POUCHOINTMENT42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28851-695-01ML - Milliliter28851-695dbfe831c-a2d8-4d9e-8a09-42f0851c0a8c12013-02-13
28851-695-02ML - Milliliter28851-69507641e1d-9f4a-4909-95e5-bc4a46bdd18b12013-02-13
28851-695-03ML - Milliliter28851-695dfb453a9-e4c2-4269-bdbb-3fecf60612a512016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
ZincACTIVE MOIETYJ41CSQ7QDSKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
1-DECENEINACTIVE INGREDIENT7O4U4C718PKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
ACETATE IONINACTIVE INGREDIENT569DQM74SCKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
BERGAMOT OILINACTIVE INGREDIENT39W1PKE3JIKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
CETYL HYDROXYETHYLCELLULOSE (350000 MW)INACTIVE INGREDIENTT7SWE4S2TTKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4KENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
JOJOBA OILINACTIVE INGREDIENT724GKU717MKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3KENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEKENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28851-695KENDALL SOOTHING (ZINC OXIDE) OINTMENT [COVIDIEN INC.]2Legacy NDC, 3 package rows20110428_46bffc62-3cd5-4493-880c-037feb7b346c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199099zinc oxide 10 % Topical OintmentPSN46bffc62-3cd5-4493-880c-037feb7b346c2
199099zinc oxide 0.1 MG/MG Topical OintmentSCD46bffc62-3cd5-4493-880c-037feb7b346c2
199099zinc oxide 10 % Topical OintmentSY46bffc62-3cd5-4493-880c-037feb7b346c2
199099ZNO 0.1 MG/MG Topical OintmentSY46bffc62-3cd5-4493-880c-037feb7b346c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
28851-695-012885106950159 mL in 1 TUBE59 mlHistorical
28851-695-0228851069502118 mL in 1 TUBE118 mlHistorical
28851-695-03288510695034 mL in 1 POUCH4 mlHistorical