Theraplex

Product NDC
62917-065
Requested package NDC
62917-065-14
11-digit product format
629170065
Labeler code
62917
Product ID
62917-065_91199a78-e92e-487e-8417-f0c5ee60d6d2
Type
HUMAN OTC DRUG
Nonproprietary name
PETROLATUM
Dosage form
CREAM
Route
TOPICAL
Labeler
The Theraplex Company, LLC
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-10-23
Marketing end
0000-00-00
Substance
PETROLATUM
Active strength
65 g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62917-06562917-065-14IInactivated 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 · 19 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

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
62917-065-022021-07-23C16284748780-1c7ccaba7-1932-fd44-e053-dadaa90aa01bTheraplex Healing Emollient
62917-065-082021-07-23C16284748780-1c7ccaba7-15c0-fd44-e053-dadaa90aa01btheraplex HEALING EMOLLIENT
62917-065-142021-07-23C16284748780-1c7ccaba7-15bd-fd44-e053-dadaa90aa01bTheraplex Healing Emollient

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62917-065-02TheraplexHealing Emollient56.6 g in 1 JARCREAM56.61
62917-065-08TheraplexHEALING EMOLLIENT226.7 g in 1 JARCREAM226.71
62917-065-14TheraplexHealing Emollient397 g in 1 JARCREAM3971

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62917-065THERAPLEX HEALING EMOLLIENT (PETROLATUM) CREAM [THE THERAPLEX COMPANY, LLC]1Legacy NDC, 1 package rows20151027_e76e2f90-8c10-4354-8dfe-b4358018645c.zip
62917-065THERAPLEX HEALING EMOLLIENT (PETROLATUM) CREAM [THE THERAPLEX COMPANY, LLC]1Legacy NDC, 1 package rows20170501_1af2e6c9-aa62-43a3-9eaf-342fe1bdd598.zip
62917-065THERAPLEX HEALING EMOLLIENT (PETROLATUM) CREAM [THE THERAPLEX COMPANY, LLC]1Legacy NDC, 1 package rows20170501_b4e90178-b6c6-49c0-b0b6-b4e73eca2094.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1716270petrolatum 65 % Topical CreamPSN1af2e6c9-aa62-43a3-9eaf-342fe1bdd5981
1716270petrolatum 65 % Topical CreamPSNb4e90178-b6c6-49c0-b0b6-b4e73eca20941
1716270petrolatum 65 % Topical CreamPSNe76e2f90-8c10-4354-8dfe-b4358018645c1
1716270petrolatum 650 MG/ML Topical CreamSCD1af2e6c9-aa62-43a3-9eaf-342fe1bdd5981
1716270petrolatum 650 MG/ML Topical CreamSCDb4e90178-b6c6-49c0-b0b6-b4e73eca20941
1716270petrolatum 650 MG/ML Topical CreamSCDe76e2f90-8c10-4354-8dfe-b4358018645c1
1716270petrolatum 65 % Topical CreamSY1af2e6c9-aa62-43a3-9eaf-342fe1bdd5981
1716270petrolatum 65 % Topical CreamSYb4e90178-b6c6-49c0-b0b6-b4e73eca20941
1716270petrolatum 65 % Topical CreamSYe76e2f90-8c10-4354-8dfe-b4358018645c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62917-065-1462917006514397 g in 1 JAR (62917-065-14) 397 g2017-05-010000-00-00NoNoCurrent