RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief

Product NDC
70692-149
11-digit product format
706920149
Labeler code
70692
Product ID
70692-149_f813df18-8e46-48b8-925e-dc4f8da0eb14
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strive Pharmaceuticals Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-13
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500; 25 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIGHT REMEDIES EXTRA STRENGTH PM Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.8badbaad-eb35-4251-a779-00474819360d2023-11-13WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash. If a skin reaction occurs, stop use and seek medical help right away. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • with any other product containing diphenhydramine, even one used on skin • in children under 12 years of age • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have • liver disease • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • glaucoma Ask a doctor or a pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers When using this product • drowsiness will occur • avoid alcoholic drinks • do not drive a motor vehicle or operate machinery Stop use and ask a doctor if • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur. These could be signs of a serious condition If pregnant or breast-feeding , ask a health professional before use. 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.

Additional Listing Data#

Finished product
Yes
Brand name base
RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, TC2D6JAD40
Rxcui1092189

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-149-03RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief1 in 1 CARTONTABLET, FILM COATED11
70692-149-03RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
70692-149-05RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief1 in 1 CARTONTABLET, FILM COATED11
70692-149-05RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief50 in 1 BOTTLE, PLASTICTABLET, FILM COATED501
70692-149-31RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief300 in 1 BOTTLE, PLASTICTABLET, FILM COATED3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-149RIGHT REMEDIES EXTRA STRENGTH PM PAIN RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [STRIVE PHARMACEUTICALS INC.]1Current NDC, 5 package rows20231214_8badbaad-eb35-4251-a779-00474819360d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN8badbaad-eb35-4251-a779-00474819360d1
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD8badbaad-eb35-4251-a779-00474819360d1
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY8badbaad-eb35-4251-a779-00474819360d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70692-149-03706920149031 BOTTLE, PLASTIC in 1 CARTON (70692-149-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2023-11-13NoNoCurrent
70692-149-05706920149051 BOTTLE, PLASTIC in 1 CARTON (70692-149-05) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2023-11-13NoNoCurrent
70692-149-3170692014931300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70692-149-31) 2023-11-13NoNoCurrent