Essential Fatty Acid Drops

Product NDC
63083-2022
Requested package NDC
63083-2022-2
11-digit product format
630832022
Labeler code
63083
Product ID
63083-2022_55b29ff4-dc09-4be7-ae75-ad1f100c408d
Type
HUMAN OTC DRUG
Nonproprietary name
Essential Fatty Acid Drops
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
LINOLENIC ACID; OENOTHERA BIENNIS WHOLE; OMEGA-6 FATTY ACIDS
Active strength
6; 6; 6 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 15 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…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Essential Fatty Acid Drops
Brand name suffix
2022
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LINOLENIC ACID6 [hp_X]/59mL
OENOTHERA BIENNIS WHOLE6 [hp_X]/59mL
OMEGA-6 FATTY ACIDS6 [hp_X]/59mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0RBV727H71Internal UNII lookup
76UI55V071Internal UNII lookup
116Z6MZN1MInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8489febd-025a-4db3-8749-9e8c657fe127Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2026-01-08C22
2026-01-08C22
2024-01-30C22
2024-01-30C22

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-2022-2Essential Fatty Acid Drops202259 mL in 1 BOTTLE, DROPPERLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-2022ESSENTIAL FATTY ACID DROPS 2022 (ESSENTIAL FATTY ACID DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220215_8489febd-025a-4db3-8749-9e8c657fe127.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Essential Fatty Acid Drops 2022ESSENTIAL FATTY ACID DROPSProfessional Complementary Health Formulas8489febd-025a-4db3-8749-9e8c657fe1272026-01-08WarningsExact identifier
ndc (package): 63083-2022-2
ndc (product): 63083-2022
ndc11 (package): 63083202202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-2022-26308320220259 mL in 1 BOTTLE, DROPPER (63083-2022-2) 59 ml1985-08-150000-00-00NoNoCurrent