Gold

Product NDC
57520-0350
11-digit product format
575200350
Labeler code
57520
Product ID
57520-0350_053cbe6f-b5f9-4b60-a683-fc24cf7285f3
Type
HUMAN OTC DRUG
Nonproprietary name
L-carnitine, L-glutamine, L-ornithine, L-tryptophan, L-tryosine, Human chorionic gonadotropin,
Dosage form
LIQUID
Route
ORAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-09-30
Marketing end
0000-00-00
Substance
LEVOCARNITINE; GLUTAMINE; ORNITHINE; TRYPTOPHAN; TYROSINE; HUMAN CHORIONIC GONADOTROPIN
Active strength
6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct57520-0350IInactivated by FDA2026-10-05
excluded packagepackage57520-035057520-0350-1IInactivated 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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57520-0350-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57520-0350-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57520-0350-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57520-0350-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57520-0350-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57520-0350-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57520-0350-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57520-0350-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57520-0350-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57520-0350-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57520-0350-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57520-0350-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage57520-0350-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage57520-0350-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage57520-0350-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage57520-0350-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57520-0350-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57520-0350-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage57520-0350-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage57520-0350-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage57520-0350-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage57520-0350-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
73df98bc-429f-4587-8299-6ad8d52a4f36Product name220250304
08c722ec-780f-bb7b-8f14-3d4f7bf0e098Product name220240205
e2f276e5-439f-b432-b5e5-b0cfa993da69Product name320220609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
4585a4fb-0028-3d95-020c-9b1c40bf15e0Product name120140508
64b87b8d-6ae7-cef1-8fd2-34228b0cc1bcProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57520-0350-12020-01-31C16284748780-19d75b9d0-cdea-f424-e053-dadaa90a57ceGold

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57520-0350-1Gold60 mL in 1 BOTTLE, DROPPERLIQUID601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLUTAMINEACTIVE INGREDIENT0RH81L854JGOLD (L-CARNITINE, L-GLUTAMINE, L-ORNITHINE, L-TRYPTOPHAN, L-TRYOSINE, HUMAN CHORIONIC GONADOTROPIN,) LIQUID [APOTHECA COMPANY]1
HUMAN CHORIONIC GONADOTROPINACTIVE INGREDIENT20ED16GHEBGOLD (L-CARNITINE, L-GLUTAMINE, L-ORNITHINE, L-TRYPTOPHAN, L-TRYOSINE, HUMAN CHORIONIC GONADOTROPIN,) LIQUID [APOTHECA COMPANY]1
LEVOCARNITINEACTIVE INGREDIENT0G389FZZ9MGOLD (L-CARNITINE, L-GLUTAMINE, L-ORNITHINE, L-TRYPTOPHAN, L-TRYOSINE, HUMAN CHORIONIC GONADOTROPIN,) LIQUID [APOTHECA COMPANY]1
ORNITHINEACTIVE INGREDIENTE524N2IXA3GOLD (L-CARNITINE, L-GLUTAMINE, L-ORNITHINE, L-TRYPTOPHAN, L-TRYOSINE, HUMAN CHORIONIC GONADOTROPIN,) LIQUID [APOTHECA COMPANY]1
TRYPTOPHANACTIVE INGREDIENT8DUH1N11BXGOLD (L-CARNITINE, L-GLUTAMINE, L-ORNITHINE, L-TRYPTOPHAN, L-TRYOSINE, HUMAN CHORIONIC GONADOTROPIN,) LIQUID [APOTHECA COMPANY]1
TYROSINEACTIVE INGREDIENT42HK56048UGOLD (L-CARNITINE, L-GLUTAMINE, L-ORNITHINE, L-TRYPTOPHAN, L-TRYOSINE, HUMAN CHORIONIC GONADOTROPIN,) LIQUID [APOTHECA COMPANY]1
GLUTAMINEACTIVE MOIETY0RH81L854JGOLD (L-CARNITINE, L-GLUTAMINE, L-ORNITHINE, L-TRYPTOPHAN, L-TRYOSINE, HUMAN CHORIONIC GONADOTROPIN,) LIQUID [APOTHECA COMPANY]1
HUMAN CHORIONIC GONADOTROPINACTIVE MOIETY20ED16GHEBGOLD (L-CARNITINE, L-GLUTAMINE, L-ORNITHINE, L-TRYPTOPHAN, L-TRYOSINE, HUMAN CHORIONIC GONADOTROPIN,) LIQUID [APOTHECA COMPANY]1
LEVOCARNITINEACTIVE MOIETY0G389FZZ9MGOLD (L-CARNITINE, L-GLUTAMINE, L-ORNITHINE, L-TRYPTOPHAN, L-TRYOSINE, HUMAN CHORIONIC GONADOTROPIN,) LIQUID [APOTHECA COMPANY]1
ORNITHINEACTIVE MOIETYE524N2IXA3GOLD (L-CARNITINE, L-GLUTAMINE, L-ORNITHINE, L-TRYPTOPHAN, L-TRYOSINE, HUMAN CHORIONIC GONADOTROPIN,) LIQUID [APOTHECA COMPANY]1
TRYPTOPHANACTIVE MOIETY8DUH1N11BXGOLD (L-CARNITINE, L-GLUTAMINE, L-ORNITHINE, L-TRYPTOPHAN, L-TRYOSINE, HUMAN CHORIONIC GONADOTROPIN,) LIQUID [APOTHECA COMPANY]1
TYROSINEACTIVE MOIETY42HK56048UGOLD (L-CARNITINE, L-GLUTAMINE, L-ORNITHINE, L-TRYPTOPHAN, L-TRYOSINE, HUMAN CHORIONIC GONADOTROPIN,) LIQUID [APOTHECA COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MGOLD (L-CARNITINE, L-GLUTAMINE, L-ORNITHINE, L-TRYPTOPHAN, L-TRYOSINE, HUMAN CHORIONIC GONADOTROPIN,) LIQUID [APOTHECA COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RGOLD (L-CARNITINE, L-GLUTAMINE, L-ORNITHINE, L-TRYPTOPHAN, L-TRYOSINE, HUMAN CHORIONIC GONADOTROPIN,) LIQUID [APOTHECA COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57520-0350GOLD (L-CARNITINE, L-GLUTAMINE, L-ORNITHINE, L-TRYPTOPHAN, L-TRYOSINE, HUMAN CHORIONIC GONADOTROPIN,) LIQUID [APOTHECA COMPANY]1Legacy NDC, 1 package rows20101002_f8bed4b0-d838-4e93-bdd1-c0b038edb32a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
57520-0350-15752003500160 mL in 1 BOTTLE, DROPPER60 mlHistorical