FDA.reportPublic FDA data

RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgel

Manufacturer
Strive Pharmaceuticals Inc.
Effective date
2025-03-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:57:46

Label at a glance#

ProductRIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgel
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

for relief of occasional sleeplessness reduces time to fall alseep if you have difficulty falling asleep

Dosage and administration

adults and children 12 years and over  take 1 softgel (50mg) at bedtime if needed, or as directed by a doctor children under 12 years  do not use

Storage and handling

store at room temperature between 20°-25°C (68°-77°F) avoid excessive heat above 40°C (104°F) protect from light, heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional sleeplessness
  • reduces time to fall alseep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have

  • glaucoma
  • heart disease
  • a breathing problem such as emphysema, asthma, or chronic bronchitis
  • difficulty in urination due to an enlargement of prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers, or any other sleep aid

When using this product

  • avoid alcoholic beverages and other drugs that cause drowsiness.
  • be careful when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over take 1 softgel (50mg) at bedtime if needed, or as directed by a doctor
children under 12 years do not use

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature between 20°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible ink, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033  Monday-Friday 8am-4pm EST

SPL UNCLASSIFIED SECTION

Compare to the active ingredient of Unisom ® SleepGels®*

fall asleep fast safe, non-habit forming

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Chatem, Inc., owner of the registered trademark Unisom®.

Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

PRODUCT OF INDIA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nighttime834-2Nighttime834-2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN2
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD2
1020477diphenhydramine HCl 50 MG Oral CapsuleSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-834-71RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgel275 in 1 BOTTLECAPSULE, LIQUID FILLED2752

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-834RIGHT REMEDIES MAXIMUM STRENGTH NIGHTTIME SLEEP-AID SOFTGEL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STRIVE PHARMACEUTICALS INC.]2Current NDC, 1 package rows20250327_2d64f5c2-dfa9-e5f5-e063-6294a90a0711.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70692-83470692-834-71

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid SoftgelDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d64f5c2-dfa9-e5f5-e063-6294a90a07112025-03-19WarningsExact identifier
ndc (package): 70692-834-71
ndc (product): 70692-834
ndc11 (package): 70692083471
spl id: 9f2a9500-3de5-4994-9143-dbebf2f4b257
spl set id: 2d64f5c2-dfa9-e5f5-e063-6294a90a0711

Reported adverse events (FAERS/openFDA)#

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