FDA.reportPublic FDA data

Rotosxika Sleep Aid Patch

Manufacturer
Puning Xinhua Trade Co., Ltd. | Nanyang Jingzhilan Biotechnology Co., Ltd.
Effective date
2023-10-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:57:24

Label at a glance#

ProductRotosxika Sleep Aid Patch
Active ingredientCHAMOMILE, DIPHENHYDRAMINE HYDROCHLORIDE, CAMPHOR (NATURAL), DOXYLAMINE SUCCINATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient:

Docylamine succinate 5g/100g, Diphenhydramine hydrochloride 3g/100g, Camphor 3g/100g, Chamomile 3g/100g

OTC - PURPOSE SECTION

Purpose: Helps sleep

INDICATIONS & USAGE SECTION

Use to:

Temporary relief of occasional mild pain, accompanying insomnia, nighttime sleep aid

DOSAGE & ADMINISTRATION SECTION

Directions:

External use. Clean the area of use, remove the release paper, and apply it to the Yongquan acupoint on the foot of the human body or the Shenque acupoint on the navel of the human body.

WARNINGS SECTION

Precautions
1.This product is an external product, do not take it internally;
2.This product is a health care product and does not replace drugs and medical devices fortreatment;
3.Pregnant women, infants, breastfeeding, and those allergic to this product are prohibited;
4.Do not use skin allergies, skin damage, skin diseases and other symptoms;
5.If the skin appears red, itchy and other abnormal conditions during use, please suspend use

OTC - QUESTIONS SECTION

Questions or comments? +8617846992567

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Spice,Glycerol,Sorbitol,Sucralose

STATEMENT OF IDENTITY SECTION

Other information:

Sealed packaging,please keep in a cool and dark place.

Produced by:
Nanyang Jingzhilan Biotechnology Co., Ltd
No.6,Road2,Longsheng Industrial Park,Wangcun Township, Wolong District, Nanyang City
OEM Company: Puning Xinhua Trade Co., Ltd

Made in China

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Same as WARNINGS SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rotosxika Sleep Aid PatchRotosxika Sleep Aid PatchLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83702-020-122025-01-30C16284748780-12cef2736-5efe-d83d-e063-dadaa90ab31fRotosxika Sleep Aid Patch 83702-020-12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83702-020-11Rotosxika Sleep Aid Patch2.1 g in 1 PATCHPATCH2.11
83702-020-12Rotosxika Sleep Aid Patch7 in 1 BAGPATCH71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83702-020ROTOSXIKA SLEEP AID PATCH (DOCYLAMINE SUCCINATE, DIPHENHYDRAMINE HYDROCHLORIDE, CHAMOMILE, CAMPHOR) PATCH [PUNING XINHUA TRADE CO., LTD.]12 package rows20231024_0810ac48-9751-ba93-e063-6294a90a8b45.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83702-02083702-020-11, 83702-020-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHAMOMILEFGL3685T2XACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CAMPHOR (NATURAL)N20HL7Q941ACTIB
SUCRALOSE96K6UQ3ZD4IACT
SORBITOL506T60A25RIACT
ALLSPICEI5GZG55B36IACT
GLYCEROL FORMAL3L7GR2604EIACT
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB

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
0810ac48-9752-ba93-e063-6294a90a8b450810ac48-9751-ba93-e063-6294a90a8b452023-10-19WarningsExact identifier
spl id: 0810ac48-9752-ba93-e063-6294a90a8b45
spl set id: 0810ac48-9751-ba93-e063-6294a90a8b45

Reported adverse events (FAERS/openFDA)#

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