Home NDC 60512-0011-1 INSOMNIA RELIEF
Product NDC 60512-0011
Requested package NDC 60512-0011-1
11-digit product format 605120011
Labeler code 60512
Product ID 60512-0011_9cbf852f-1c82-13ea-e053-2995a90a7878
Type HUMAN OTC DRUG
Nonproprietary name PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER
Dosage form PELLET
Route ORAL
Labeler HOMEOLAB USA INC.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2013-10-18
Marketing end 0000-00-00
Substance PASSIFLORA INCARNATA TOP; VALERIAN; AVENA SATIVA FLOWERING TOP; CUPRIC ACETATE; HYOSCYAMUS NIGER WHOLE
Active strength 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVENA SATIVA FLOWERING TOP ACTIVE INGREDIENT MA9CQJ3F7F INSOMNIA RELIEF (PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER) PELLET [HOMEOLAB USA INC.] 2 CUPRIC ACETATE ACTIVE INGREDIENT 39M11XPH03 INSOMNIA RELIEF (PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER) PELLET [HOMEOLAB USA INC.] 2 HYOSCYAMUS NIGER WHOLE ACTIVE INGREDIENT 34412PDT5E INSOMNIA RELIEF (PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER) PELLET [HOMEOLAB USA INC.] 2 PASSIFLORA INCARNATA TOP ACTIVE INGREDIENT CLF5YFS11O INSOMNIA RELIEF (PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER) PELLET [HOMEOLAB USA INC.] 2 VALERIAN ACTIVE INGREDIENT JWF5YAW3QW INSOMNIA RELIEF (PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER) PELLET [HOMEOLAB USA INC.] 2 AVENA SATIVA FLOWERING TOP ACTIVE MOIETY MA9CQJ3F7F INSOMNIA RELIEF (PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER) PELLET [HOMEOLAB USA INC.] 2 CUPRIC CATION ACTIVE MOIETY 8CBV67279L INSOMNIA RELIEF (PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER) PELLET [HOMEOLAB USA INC.] 2 HYOSCYAMUS NIGER WHOLE ACTIVE MOIETY 34412PDT5E INSOMNIA RELIEF (PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER) PELLET [HOMEOLAB USA INC.] 2 PASSIFLORA INCARNATA FLOWERING TOP ACTIVE MOIETY CLF5YFS11O INSOMNIA RELIEF (PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER) PELLET [HOMEOLAB USA INC.] 2 VALERIAN ACTIVE MOIETY JWF5YAW3QW INSOMNIA RELIEF (PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER) PELLET [HOMEOLAB USA INC.] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G INSOMNIA RELIEF (PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER) PELLET [HOMEOLAB USA INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 INSOMNIA RELIEF (PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER) PELLET [HOMEOLAB USA INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60512-0011 INSOMNIA RELIEF (PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER) PELLET [HOMEOLAB USA INC.] 4 Legacy NDC 20200123_1c2531fe-75fe-4dcc-9ea9-d927f70cc4fb.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60512-0011-1 60512001101 80 PELLET in 1 TUBE (60512-0011-1) 80 pellet 2013-10-18 0000-00-00 No No Current