AZADIRACHTA INDICA

Manufacturer: Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | Rxhomeo, Inc
Effective date: 2015-12-31
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:07:16

Label at a glance#

ProductAZADIRACHTA INDICA

Active ingredientAZADIRACHTA INDICA BARK

Label structure9 sections

Indications and uses

Skin disorders

Storage and handling

Store in a cool dark place

Contacts and useful links#

Websitewww.rxhomeo.com

www.Rxhomeo.com

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

AZADIRACHTA INDICA HPUS 1X and Higher

USES

OTC - PURPOSE SECTION

Skin disorders

INDICATIONS

INDICATIONS & USAGE SECTION

Condition listed above or as directed by the physician

DOSAGE

DOSAGE & ADMINISTRATION SECTION

Adults- Take 4 or 6 Tablets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

WARNINGS

WARNINGS SECTION

This product is to be used for self-limiting conditions

OTC - STOP USE SECTION

If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children

OTC - DO NOT USE SECTION

Do not use if capseal is broken or missing.

Close the cap tightly after use.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Lactose

STORAGE

STORAGE AND HANDLING SECTION

Store in a cool dark place

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com

Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
15631-0531-0	2020-01-31	C162847	48780-1	9d75b9d0-ad11-f424-e053-dadaa90a57ce	d47f6ee5-8609-4992-b54c-66417f37da51
15631-0531-1	2020-01-31	C162847	48780-1	9d75b9d0-ad11-f424-e053-dadaa90a57ce	d47f6ee5-8609-4992-b54c-66417f37da51
15631-0531-2	2020-01-31	C162847	48780-1	9d75b9d0-ad11-f424-e053-dadaa90a57ce	d47f6ee5-8609-4992-b54c-66417f37da51
15631-0531-3	2020-01-31	C162847	48780-1	9d75b9d0-ad11-f424-e053-dadaa90a57ce	d47f6ee5-8609-4992-b54c-66417f37da51
15631-0531-4	2020-01-31	C162847	48780-1	9d75b9d0-ad11-f424-e053-dadaa90a57ce	d47f6ee5-8609-4992-b54c-66417f37da51
15631-0531-5	2020-01-31	C162847	48780-1	9d75b9d0-ad11-f424-e053-dadaa90a57ce	d47f6ee5-8609-4992-b54c-66417f37da51
15631-0531-6	2020-01-31	C162847	48780-1	9d75b9d0-ad11-f424-e053-dadaa90a57ce	d47f6ee5-8609-4992-b54c-66417f37da51
15631-0531-7	2020-01-31	C162847	48780-1	9d75b9d0-ad11-f424-e053-dadaa90a57ce	d47f6ee5-8609-4992-b54c-66417f37da51

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
15631-0531-0	AZADIRACHTA INDICA	1 in 1 BLISTER PACK	TABLET	1	1
15631-0531-1	AZADIRACHTA INDICA	4 in 1 BLISTER PACK	TABLET	4	1
15631-0531-2	AZADIRACHTA INDICA	50 in 1 CONTAINER	TABLET	50	1
15631-0531-3	AZADIRACHTA INDICA	100 in 1 CONTAINER	TABLET	100	1
15631-0531-4	AZADIRACHTA INDICA	250 in 1 CONTAINER	TABLET	250	1
15631-0531-5	AZADIRACHTA INDICA	500 in 1 CONTAINER	TABLET	500	1
15631-0531-6	AZADIRACHTA INDICA	1000 in 1 CONTAINER	TABLET	1000	1
15631-0531-7	AZADIRACHTA INDICA	10000 in 1 CONTAINER	TABLET	10000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15631-0531	AZADIRACHTA INDICA TABLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]	1	Legacy NDC, 8 package rows	20160104_d47f6ee5-8609-4992-b54c-66417f37da51.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

AZADIRACHTA INDICA
AZADIRACHTA INDICA BARK
LACTOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
15631-0531	15631-0531-0, 15631-0531-1, 15631-0531-2, 15631-0531-3, 15631-0531-4, 15631-0531-5, 15631-0531-6, 15631-0531-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AZADIRACHTA INDICA BARK	G580B439YI	ACTIB
LACTOSE	J2B2A4N98G	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
9dc18d3f-bfa5-438b-a061-14b43460f463			d47f6ee5-8609-4992-b54c-66417f37da51	2015-12-31	Warnings	Exact identifier spl id: 9dc18d3f-bfa5-438b-a061-14b43460f463 spl set id: d47f6ee5-8609-4992-b54c-66417f37da51

Reported adverse events (FAERS/openFDA)#

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