Pain Reliever PM

Product NDC
55319-562
11-digit product format
553190562
Labeler code
55319
Product ID
55319-562_fdfb0fb4-b274-4c61-ab00-62c6770dfcf3
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-01
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
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLFamily Dollar (FAMILY WELLNESS)7a98d4d9-54e2-45c1-a76a-7f1907566e952026-06-01WarningsExact 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 products 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 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 a serious underlying medical illness. pain gets worse or last more than 10 days fever gets worse or last 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Reliever PM
Listing expiration
2027-12-31

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
55319-562-10Pain Reliever PM100 in 1 BOTTLE, PLASTICTABLET, COATED1007
55319-562-10Pain Reliever PM1 in 1 BOXTABLET, COATED17
55319-562-24Pain Reliever PM24 in 1 BOTTLE, PLASTICTABLET, COATED247
55319-562-24Pain Reliever PM1 in 1 BOXTABLET, COATED17
55319-562-50Pain Reliever PM1 in 1 BOXTABLET, COATED17
55319-562-50Pain Reliever PM50 in 1 BOTTLE, PLASTICTABLET, COATED507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-562PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [FAMILY DOLLAR (FAMILY WELLNESS)]6Current NDC, 6 package rows20250410_7a98d4d9-54e2-45c1-a76a-7f1907566e95.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55319-562-10553190562101 BOTTLE, PLASTIC in 1 BOX (55319-562-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2023-07-01NoNoCurrent
55319-562-24553190562241 BOTTLE, PLASTIC in 1 BOX (55319-562-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2023-07-01NoNoCurrent
55319-562-50553190562501 BOTTLE, PLASTIC in 1 BOX (55319-562-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2023-07-01NoNoCurrent