FDA.reportPublic FDA data

A and D plus E

Product NDC
61554-200
Requested package NDC
61554-200-01
11-digit product format
615540200
Labeler code
61554
Product ID
61554-200_b37271a5-40e1-5d0d-e053-2a95a90a66b5
Type
HUMAN OTC DRUG
Nonproprietary name
Vitamin A, D, and E Ointment
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Gentell, Inc.
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-11-03
Marketing end
0000-00-00
Substance
PETROLATUM
Active strength
1 g/g
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage61554-20061554-200-01IInactivated 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 · 9 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…
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…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61554-200-012025-07-29A&D+E Ointment
61554-200-022025-07-29A&D+E Ointment
61554-200-032025-07-29A&D+E Ointment
61554-200-042025-07-29A&D+E Ointment
61554-200-052025-07-29A&D+E Ointment
61554-200-062025-07-29A&D+E Ointment
61554-200-012024-08-08A&D+E Ointment
61554-200-022024-08-08A&D+E Ointment
61554-200-032024-08-08A&D+E Ointment
61554-200-042024-08-08A&D+E Ointment
61554-200-052024-08-08A&D+E Ointment
61554-200-062024-08-08A&D+E Ointment
61554-200-012022-01-28A&D+E Ointment
61554-200-022022-01-28A&D+E Ointment
61554-200-032022-01-28A&D+E Ointment
61554-200-042022-01-28A&D+E Ointment
61554-200-052022-01-28A&D+E Ointment
61554-200-062022-01-28A&D+E Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61554-200-01A and D plus E56.7 g in 1 TUBEOINTMENT56.75
61554-200-02A and D plus E113.4 g in 1 TUBEOINTMENT113.45
61554-200-03A and D plus E368.5 g in 1 JAROINTMENT368.55
61554-200-04A and D plus E453.6 g in 1 JAROINTMENT453.65
61554-200-05A and D plus E567 g in 1 JAROINTMENT5675
61554-200-06A and D plus E5 g in 1 PACKETOINTMENT55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61554-200A AND D PLUS E (VITAMIN A, D, AND E OINTMENT) OINTMENT [GENTELL, INC.]5Legacy NDC, 6 package rows20240809_9b804a84-0b1b-33a8-e053-2a95a90a19ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1302906petrolatum 99.9 % Topical OintmentPSN9b804a84-0b1b-33a8-e053-2a95a90a19ee5
1302906petrolatum 0.999 MG/MG Topical OintmentSCD9b804a84-0b1b-33a8-e053-2a95a90a19ee5
1302906petrolatum 99.85 % Topical OintmentSY9b804a84-0b1b-33a8-e053-2a95a90a19ee5
1302906petrolatum 99.89 % Topical OintmentSY9b804a84-0b1b-33a8-e053-2a95a90a19ee5
1302906petrolatum 99.9 % Topical OintmentSY9b804a84-0b1b-33a8-e053-2a95a90a19ee5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61554-200-016155402000156.7 g in 1 TUBE (61554-200-01) 56.7 g2014-11-030000-00-00NoNoCurrent