Home NDC 53852-0008 FEM Remedy
Product NDC 53852-0008
11-digit product format 538520008
Labeler code 53852
Product ID 53852-0008_b46f7bcf-92b0-4293-9368-68203c4d7a31
Type HUMAN OTC DRUG
Nonproprietary name Amyl nitrosum, Calcarea carbonica, Cimicifuga racemosa, Ferrum metallicum, Sanguinaria canadensis, Sepia
Dosage form LIQUID
Route ORAL
Labeler Living Well Remedies, LLC
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2014-07-16
Marketing end 0000-00-00
Substance AMYL NITRITE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; BLACK COHOSH; IRON; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE
Active strength 10 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL
NDC exclude flag E
Listing certified through 2018-12-31
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 Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53852-0008-2 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53852-0008-2 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53852-0008-2 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53852-0008-2 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53852-0008-2 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53852-0008-2 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53852-0008-2 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53852-0008-2 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53852-0008-2 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53852-0008-2 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53852-0008-2 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53852-0008-2 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53852-0008-2 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53852-0008-2 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53852-0008-2 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53852-0008-2 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53852-0008-2 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53852-0008-2 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53852-0008-2 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53852-0008-2 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53852-0008-2 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53852-0008-2 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53852-0008-2 FEM Remedy 59 mL in 1 BOTTLE, SPRAY LIQUID 59 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMYL NITRITE ACTIVE INGREDIENT 22T8Z09XAK FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC] 2 BLACK COHOSH ACTIVE INGREDIENT K73E24S6X9 FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC] 2 IRON ACTIVE INGREDIENT E1UOL152H7 FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC] 2 OYSTER SHELL CALCIUM CARBONATE, CRUDE ACTIVE INGREDIENT 2E32821G6I FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC] 2 SANGUINARIA CANADENSIS ROOT ACTIVE INGREDIENT N9288CD508 FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC] 2 SEPIA OFFICINALIS JUICE ACTIVE INGREDIENT QDL83WN8C2 FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC] 2 AMYL NITRITE ACTIVE MOIETY 22T8Z09XAK FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC] 2 BLACK COHOSH ACTIVE MOIETY K73E24S6X9 FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC] 2 IRON ACTIVE MOIETY E1UOL152H7 FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC] 2 OYSTER SHELL CALCIUM CARBONATE, CRUDE ACTIVE MOIETY 2E32821G6I FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC] 2 SANGUINARIA CANADENSIS ROOT ACTIVE MOIETY N9288CD508 FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC] 2 SEPIA OFFICINALIS JUICE ACTIVE MOIETY QDL83WN8C2 FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC] 2 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53852-0008 FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC] 2 Legacy NDC, 1 package rows 20140716_2aff35e2-4c66-4b18-89fe-f6c3e2f91cfc.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 53852-0008-2 53852000802 59 mL in 1 BOTTLE, SPRAY 59 ml Historical