FDA.reportPublic FDA data

Sleep Aid Plus Pain Relief

Product NDC
0363-9074
11-digit product format
003639074
Labeler code
0363
Product ID
0363-9074_15456d4d-c92f-4dbb-854f-9f6b4bf715a7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Walgreen Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-27
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
1000; 50 mg/30mL; mg/30mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep Aid Plus Pain Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN1000 mg/30mL
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1092373Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e3929179-dad2-4f7e-a971-dbf80f2b5e1bAvailable on FDA.report

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
0363-9074-02Sleep Aid Plus Pain Relief355 mL in 1 BOTTLE, PLASTICSOLUTION3557

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9074SLEEP AID PLUS PAIN RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) SOLUTION [WALGREEN COMPANY]6Current NDC, Legacy NDC, 1 package rows20240616_e3929179-dad2-4f7e-a971-dbf80f2b5e1b.zip

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 27 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREENS CO.d92d97a8-0ee3-1206-e053-2a95a90a72a82025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSAM'S WEST INC0c8e7095-0806-4501-e063-6394a90a89aa2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREEN CO.b3763182-2428-155a-e053-2995a90ab5782025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREENSe467b78e-9f23-5563-e053-2a95a90a586e2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWalgreensfd7c3250-35d4-494a-e053-6394a90a2db52025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INC1ddb8a2b-3081-3eda-e063-6294a90ab82b2025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCb1307d52-10e6-46e1-e053-2995a90a03b62025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCc2c6d6a1-b492-506d-e053-2995a90aac232025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENFAMILY DOLLARf8383108-0970-9f1e-e053-6294a90ad38f2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC591ee107-e953-4982-b75f-13a0afd7c4ae2025-12-19WarningsExact identifier
application number: M013
Nuvicare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENUVICARE LLC3ede0fb6-c089-4253-9878-2b01c39e9c872025-12-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINNUVICARE LLC3a4aa3c7-b726-4303-8803-74196fa5637a2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e2025-12-19WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINENUVICARE LLC32a5611b-9bf6-4850-a7ff-fa240da04f452025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e96d0-746e-fb42-e053-2a95a90a19572025-12-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e5dc0-96eb-47b2-e053-2995a90add0e2025-12-18WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.ac0f8d5c-d200-1156-e053-2a95a90aece62025-12-18WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe55645ab-66f9-4160-8247-395bc5b027112025-12-18WarningsExact identifier
application number: M013
Dolex ForteACETAMINOPHEN, ASPIRIN, CAFFEINEPharmadel LLC3c2d90fc-130d-476c-e063-6294a90a8c152025-12-17WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company07bc6632-fabb-427d-81f3-c27c54caa6a02025-12-17WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092373acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG in 15 mL Oral SolutionPSNe3929179-dad2-4f7e-a971-dbf80f2b5e1b7
1092373acetaminophen 33.3 MG/ML / diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCDe3929179-dad2-4f7e-a971-dbf80f2b5e1b7
1092373acetaminophen 1000 MG / diphenhydramine HCl 50 MG per 30 ML Oral SolutionSYe3929179-dad2-4f7e-a971-dbf80f2b5e1b7
1092373acetaminophen 500 MG / diphenhydramine HCl 25 MG per 15 ML Oral SolutionSYe3929179-dad2-4f7e-a971-dbf80f2b5e1b7
1092373APAP 33.3 MG/ML / Diphenhydramine Hydrochloride 1.67 MG/ML Oral SolutionSYe3929179-dad2-4f7e-a971-dbf80f2b5e1b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9074-0200363907402355 mL in 1 BOTTLE, PLASTIC (0363-9074-02) 355 ml2022-08-270000-00-00NoNoCurrent