FDA.reportPublic FDA data

Pain Formula

Manufacturer
Nutritional Specialties, Inc.
Effective date
2023-11-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:24:54

Label at a glance#

ProductPain Formula
Active ingredientSALIX ALBA BARK, ASCORBIC ACID, VITAMIN A, .ALPHA.-TOCOPHEROL, ASPIRIN
Label structure9 sections

Dosage and administration

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Salix Alba 4X, 6X, Ascorbicum Acidum (Vitamin C) 6X, Vitamin A 6X, Vitamin E 6X, Acetylsalicylicum Acidum 6X, 30X.

PURPOSE:

OTC - PURPOSE SECTION

Aids in temporary relief of minor aches and pains of muscles and joints†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

Professional Use Only

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

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

Aids in temporary relief of minor aches and pains of muscles and joints†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Alcohol USP 20%, Purified Water USP.

QUESTIONS:

OTC - QUESTIONS SECTION

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Professional

Health Products

HOMEOPATHIC

NDC 83027-0103-1

PAIN FORMULA

2 FL. OZ (60 ml)

PAIN FORMULAPAIN FORMULA

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0103-1Pain Formula60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0103PAIN FORMULA (SALIX ALBA, ASCORBICUM ACIDUM, VITAMIN A, VITAMIN E, ACETYLSALICYLICUM ACIDUM) SPRAY [NUTRITIONAL SPECIALTIES, INC.]1Current NDC, 1 package rows20231121_0cc0d205-83c2-4205-a93c-6a8ba55956d4.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83027-010383027-0103-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALIX ALBA BARK205MXS71H7ACTIB
ASCORBIC ACIDPQ6CK8PD0RACTIB
VITAMIN A81G40H8B0TACTIB
.ALPHA.-TOCOPHEROLH4N855PNZ1ACTIB
ASPIRINR16CO5Y76EACTIB
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
Pain FormulaSALIX ALBA, ASCORBICUM ACIDUM, VITAMIN A, VITAMIN E, ACETYLSALICYLICUM ACIDUMNutritional Specialties, Inc.0cc0d205-83c2-4205-a93c-6a8ba55956d42023-11-20WarningsExact identifier
ndc (package): 83027-0103-1
ndc (product): 83027-0103
ndc11 (package): 83027010301
spl id: ea5be260-d197-423c-9e0c-7f118e419b38
spl set id: 0cc0d205-83c2-4205-a93c-6a8ba55956d4

Reported adverse events (FAERS/openFDA)#

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