FDA.reportPublic FDA data

Spinalmax

Manufacturer
Deseret Biologicals, Inc. | Apotheca Company
Effective date
2024-03-11
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:26:19

Label at a glance#

ProductSpinalmax
Active ingredientBERBERIS VULGARIS ROOT BARK, BLACK COHOSH, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, RHODODENDRON TOMENTOSUM LEAFY TWIG, RANUNCULUS BULBOSUS, HORSE CHESTNUT, CUPRIC ACETATE, NADIDE, SODIUM DIETHYL OXALACETATE, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE, ALPHA LIPOIC ACID, AMMONIUM CHLORIDE, SUS SCROFA CARTILAGE, SUS SCROFA INTERVERTEBRAL DISC, PICRIC ACID, SILICON DIOXIDE, SILVER, TRIBASIC CALCIUM PHOSPHATE, SUS SCROFA UMBILICAL CORD, SUS SCROFA ADRENAL GLAND, PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE, SUS SCROFA BONE MARROW, MERCURIC OXIDE, PANTOTHENIC ACID, SULFUR, ENTEROBACTER CLOACAE, SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS, PROTEUS MORGANII, PROTEUS VULGARIS
Label structure9 sections

Dosage and administration

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Aesculus Hippocastanum 6X, Alpha-Lipoicum Acidum 8X, Ammonium Muriaticum 8X, Argentum Metallicum 10X, Bacillus 7 (enterobacter cloacae) 30C, Berberis Vulgaris 4X, Calcarea Phosphorica 10X, Cartilago Suis 8X, Cimicifuga Racemosa 4X, Cinchona Officinalis 4X, Colocynthis 4X, Cuprum Aceticum 6X, Discus Intervertebralis Suis 8X, Funiculus Umbilicalis Suis 10X, Gaertner Bacillus (Bach) 30C, Glandula Suprarenalis Suis 10X, Gnaphalium Polycephalum 10X, Ledum Palustre 4X, Medulla Ossis Suis 10X, Mercurius Praecipitatus Ruber 10X, Nadidum 6X, Natrum Oxalaceticum 6X, Nicotinamidum 6X, Pantothenic Acid 10X, Picricum Acidum 8X, Proteus (Morgani, Vulgaris) 30C, Pyridoxinum Hydrochloricum 6X, Ranunculus Bulbosus 4X, Riboflavinum 6X, Silicea 8X, Sulphur 28X, Thiaminum Hydrochloricum 6X.

PURPOSE:

OTC - PURPOSE SECTION

Aesculus Hippocastanum – Back Discomfort, Alpha-Lipoicum Acidum – Back Spasms, Ammonium Muriaticum – Back Pain, Argentum Metallicum - Anxiety, Bacillus 7 (Enterobacter Cloacae) – Back Pain, Berberis Vulgaris – Back Discomfort, Calcarea Phosphorica – Back Spasms, Cartilago Suis - Anxiety, Cimicifuga Racemosa – Back Discomfort, Cinchona Officinalis – Back Spasms, Colocynthis – Back Pain, Cuprum Aceticum – Back Spasms, Discus Intervertebralis Suis – Back Pain, Funiculus Umbilicalis Suis – Back Discomfort, Gaertner Bacillus (Bach) - Anxiety, Glandula Suprarenalis Suis - Nervousness, Gnaphalium Polycephalum – Back Pain, Ledum Palustre - Nervousness, Medulla Ossis Suis - Nervousness, Mercurius Praecipitatus Ruber - Anxiety, Nadidum – Back Discomfort, Natrum Oxalaceticum – Back Discomfort, Nicotinamidum – Back Spasms, Pantothenic Acid – Nervousness, Picricum Acidum – Back Discomfort, Proteus (Morgani, Vulgaris) – Back Pain, Pyridoxinum Hydrochloricum - Anxiety, Ranunculus Bulbosus – Back Discomfort, Riboflavinum – Back Spasms, Silicea – Back Pain, Sulphur – Anxiety, Thiaminum Hydrochloricum – Back Pain

INDICATION:

INDICATIONS & USAGE SECTION

• For the temporary relief of symptoms including:

• back discomfort  • back spasms

• back pain  • anxiety  • nervousness

These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

Tamper Evident: Sealed for your protection. Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, contact a physician or Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 25% ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. By: Deseret Biologicals, Inc.
469 W. Parkland Drive
Sandy, UT 84070

www.desbio.com

800-827-8204

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DesBio

Spinalmax

Homeopathic

NDC 43742-1326-1

1 FL OZ (30 ml)

SpinalmaxSpinalmax

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43742-1326-1Spinalmax30 mL in 1 BOTTLE, DROPPERLIQUID307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43742-1326SPINALMAX (BERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS (SUIS), PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM) LIQUID [DESERET BIOLOGICALS, INC.]7Current NDC, Legacy NDC, 1 package rows20240312_6c569331-2167-44bb-ace6-13340e7d8d6a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43742-132643742-1326-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
BLACK COHOSHK73E24S6X9ACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
RHODODENDRON TOMENTOSUM LEAFY TWIG877L01IZ0PACTIB
RANUNCULUS BULBOSUSAEQ8NXJ0MBACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
CUPRIC ACETATE39M11XPH03ACTIB
NADIDE0U46U6E8UKACTIB
SODIUM DIETHYL OXALACETATE6CA025Y4FGACTIB
NIACINAMIDE25X51I8RD4ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIM
RIBOFLAVINTLM2976OFRACTIB
THIAMINE HYDROCHLORIDEM572600E5PACTIB
ALPHA LIPOIC ACID73Y7P0K73YACTIB
AMMONIUM CHLORIDE01Q9PC255DACTIM
SUS SCROFA CARTILAGE73ECW5WG2FACTIB
SUS SCROFA INTERVERTEBRAL DISCOJ17O2WTSMACTIB
PICRIC ACIDA49OS0F91SACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
SILVER3M4G523W1GACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
SUS SCROFA UMBILICAL CORD118OYG6W3HACTIB
SUS SCROFA ADRENAL GLAND398IYQ16YVACTIB
PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE36XQ854NWWACTIB
SUS SCROFA BONE MARROWVP2CN2G7Y8ACTIB
MERCURIC OXIDEIY191986AOACTIB
PANTOTHENIC ACID19F5HK2737ACTIB
SULFUR70FD1KFU70ACTIB
ENTEROBACTER CLOACAE40OMQ8YEPDACTIB
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDISY3V16D4PV4ACTIB
PROTEUS MORGANII56X6LID5ZYACTIB
PROTEUS VULGARIS11T9HCO30OACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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
SpinalmaxBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS (SUIS), PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUMDeseret Biologicals, Inc.6c569331-2167-44bb-ace6-13340e7d8d6a2024-03-11WarningsExact identifier
ndc (package): 43742-1326-1
ndc (product): 43742-1326
ndc11 (package): 43742132601
spl id: a08a46a4-cb9e-442b-8639-967163c0b1eb
spl set id: 6c569331-2167-44bb-ace6-13340e7d8d6a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.