Home NDC 54616-001 BALANCE
Product NDC 54616-001
11-digit product format 546160001
Labeler code 54616
Product ID 54616-001_3dc4cafe-10de-489f-8d54-94538a3678b1
Type HUMAN OTC DRUG
Nonproprietary name Bryonia, Ignatia, Nux Vom, Phos, Sepia
Dosage form SPRAY
Route SUBLINGUAL
Labeler BDMP, LLC
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2013-02-21
Marketing end 0000-00-00
Substance BRYONIA ALBA ROOT; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SEPIA OFFICINALIS JUICE
Active strength 30 [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 54616-001-60 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 54616-001-60 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 54616-001-60 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 54616-001-60 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 54616-001-60 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 54616-001-60 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 54616-001-60 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 54616-001-60 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 54616-001-60 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 54616-001-60 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 54616-001-60 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 54616-001-60 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 54616-001-60 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 54616-001-60 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 54616-001-60 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 54616-001-60 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 54616-001-60 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 54616-001-60 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 54616-001-60 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 54616-001-60 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 54616-001-60 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 54616-001-60 110d247fa046…a55b01930146…
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54616-001-60 BALANCE 1 in 1 CARTON SPRAY 1 1 54616-001-60 BALANCE 60 mL in 1 BOTTLE, SPRAY SPRAY 60 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BRYONIA ALBA ROOT ACTIVE INGREDIENT T7J046YI2B BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 PHOSPHORUS ACTIVE INGREDIENT 27YLU75U4W BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 SEPIA OFFICINALIS JUICE ACTIVE INGREDIENT QDL83WN8C2 BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 STRYCHNOS IGNATII SEED ACTIVE INGREDIENT 1NM3M2487K BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 STRYCHNOS NUX-VOMICA SEED ACTIVE INGREDIENT 269XH13919 BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 BRYONIA ALBA ROOT ACTIVE MOIETY T7J046YI2B BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 PHOSPHORUS ACTIVE MOIETY 27YLU75U4W BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 SEPIA OFFICINALIS JUICE ACTIVE MOIETY QDL83WN8C2 BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 STRYCHNOS IGNATII SEED ACTIVE MOIETY 1NM3M2487K BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 STRYCHNOS NUX-VOMICA SEED ACTIVE MOIETY 269XH13919 BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 BARBASCO INACTIVE INGREDIENT 5ZAQ44W04C BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 BLACK COHOSH INACTIVE INGREDIENT K73E24S6X9 BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 DULACIA INOPIFLORA WOOD INACTIVE INGREDIENT K04M7D9VEC BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 ELEUTHERO INACTIVE INGREDIENT ZQH6VH092Z BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 MALIC ACID INACTIVE INGREDIENT 817L1N4CKP BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 STEVIA REBAUDIUNA LEAF INACTIVE INGREDIENT 6TC6NN0876 BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 TRIBULUS TERRESTRIS INACTIVE INGREDIENT 4X4HLN92OT BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 TURNERA DIFFUSA LEAFY TWIG INACTIVE INGREDIENT RQ2CFA7WWJ BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 WATER INACTIVE INGREDIENT 059QF0KO0R BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54616-001 BALANCE (BRYONIA, IGNATIA, NUX VOM, PHOS, SEPIA) SPRAY [BDMP, LLC ] 1 Legacy NDC, 2 package rows 20130227_8010500e-451e-4a80-9908-20950e8f69f9.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 54616-001-60 54616000160 1 in 1 CARTON Historical