Relaxoforce

Product NDC
43857-0545
Requested package NDC
43857-0545-1
11-digit product format
438570545
Labeler code
43857
Product ID
43857-0545_a57d489a-e899-49a0-a47a-c8a134322b2a
Type
HUMAN OTC DRUG
Nonproprietary name
Humulus Lupulus, Passiflora Incarnata, Valeriana Officinalis, Calcarea Carbonica, Coffea Tosta, Ignatia Amara, Kali Phosphoricum, Moschus, Nux Vomica, Phosphorus, Pulsatilla (Pratensis)
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-02-19
Substance
COFFEA ARABICA SEED, ROASTED; DIBASIC POTASSIUM PHOSPHATE; HOPS; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PULSATILLA PRATENSIS WHOLE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; VALERIAN
Active strength
12; 12; 3; 12; 12; 3; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43857-054543857-0545-1IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43857-054543857-0545-1IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43857-054543857-0545-1IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

Additional Listing Data#

Finished product
Yes
Brand name base
Relaxoforce
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOPS12 [hp_X]/mL
PASSIFLORA INCARNATA FLOWERING TOP12 [hp_X]/mL
VALERIAN3 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]/mL
COFFEA ARABICA SEED, ROASTED12 [hp_X]/mL
STRYCHNOS IGNATII SEED3 [hp_X]/mL
DIBASIC POTASSIUM PHOSPHATE12 [hp_X]/mL
MOSCHUS MOSCHIFERUS MUSK SAC RESIN12 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE3 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
01G73H6H83Internal UNII lookup
CLF5YFS11OInternal UNII lookup
JWF5YAW3QWInternal UNII lookup
2E32821G6IInternal UNII lookup
9H58JRT35EInternal UNII lookup
1NM3M2487KInternal UNII lookup
CI71S98N1ZInternal UNII lookup
8KFK4W7KP7Internal UNII lookup
269XH13919Internal UNII lookup
27YLU75U4WInternal UNII lookup
8E272251DIInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
141fb6b7-08d9-4b57-bafd-ba5c8f98914eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0545-12023-11-30C16284748780-1d6a99b39-38f2-a426-e053-dadaa90af4c2DRUG FACTS:
43857-0545-12022-01-28C16284748780-1d6a99b39-38f2-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0545-1Relaxoforce30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0545RELAXOFORCE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, CALCAREA CARBONICA, COFFEA TOSTA, IGNATIA AMARA, KALI PHOSPHORICUM, MOSCHUS, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20250403_141fb6b7-08d9-4b57-bafd-ba5c8f98914e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RelaxoforceHUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, CALCAREA CARBONICA, COFFEA TOSTA, IGNATIA AMARA, KALI PHOSPHORICUM, MOSCHUS, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS)BioActive Nutritional, Inc.141fb6b7-08d9-4b57-bafd-ba5c8f98914e2026-03-11WarningsExact identifier
ndc (package): 43857-0545-1
ndc (product): 43857-0545
ndc11 (package): 43857054501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0545-14385705450130 mL in 1 BOTTLE, DROPPER (43857-0545-1) 30 ml2020-02-190000-00-00NoNoCurrent