FDA.reportPublic FDA data

Menopause Plus Sleep

Product NDC
54973-3356
11-digit product format
549733356
Labeler code
54973
Product ID
54973-3356_efb79f0c-cc1f-d1bf-e053-2995a90a66d6
Type
HUMAN OTC DRUG
Nonproprietary name
ATROPA BELLADONNA, CAULOPHYLLUM THALICTROIDES ROOT, BLACK COHOSH, NITROGLYCERIN, STRYCHNOS IGNATII SEED, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, SULFUR and LACHESIS MUTA VENOM
Dosage form
KIT
Route
SUBLINGUAL
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-06-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct54973-3356DDiscontinued by firm2026-10-05
excluded packagepackage54973-335654973-3356-1DDiscontinued by firm2026-10-05

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 · 4 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54973-3356-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54973-3356-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…

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
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54973-3356-12022-10-20C16284748780-1e4f33bdf-a124-d8a0-e053-dadaa90a6e4eDoctor Wise Menopause+ Sleep
54973-3356-12022-07-29C16284748780-1e4f33bdf-a124-d8a0-e053-dadaa90a6e4eDoctor Wise Menopause+ Sleep

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3356MENOPAUSE PLUS SLEEP (ATROPA BELLADONNA, CAULOPHYLLUM THALICTROIDES ROOT, BLACK COHOSH, NITROGLYCERIN, STRYCHNOS IGNATII SEED, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, SULFUR AND LACHESIS MUTA VENOM) KIT [HYLAND'S INC.]2Legacy NDC20221217_6ac64478-7fb8-4cac-e053-2991aa0a9db0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54973-3356-1549733356011 KIT in 1 CARTON (54973-3356-1) * 4 TABLET in 1 PACKET (54973-3355-2) * 60 TABLET in 1 BOTTLE, PLASTIC (54973-3355-1) 1 kit2018-06-010000-00-00NoNoCurrent