FDA.reportPublic FDA data

ADWE dye-free childrens allergy

Product NDC
68163-710
11-digit product format
681630710
Labeler code
68163
Product ID
68163-710_3a1d821f-239d-4a4f-e063-6294a90ae3da
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
RARITAN PHARMACEUTICALS INC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-22
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/5mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
ADWE dye-free childrens allergy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049906Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea3a51af-3025-497f-8cd7-e99391b0d06fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68163-710-08ADWE dye-free childrens allergy1 in 1 CARTONSYRUP15
68163-710-08ADWE dye-free childrens allergy236 mL in 1 BOTTLE, PLASTICSYRUP2365

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68163-710ADWE DYE-FREE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [RARITAN PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 2 package rows20240719_ea3a51af-3025-497f-8cd7-e99391b0d06f.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 1 of 14 · 263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wal Som Nighttime Sleep AidDIPHENHYDRAMINE HCLWalgreensff475a69-dbb2-40a9-b7f4-9c7b7e975d192026-07-23WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporation336ac29d-db24-44da-a299-5a4793ae8f6a2026-07-21WarningsExact identifier
application number: M010
Best Choice Childrens Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLBEST CHOICE (VALU MERCHANDISERS COMPANY)9bf2d698-8394-46c3-b7a9-e99ab6bb88e42026-07-17WarningsExact identifier
application number: M010
ADWE dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDERARITAN PHARMACEUTICALS INCea3a51af-3025-497f-8cd7-e99391b0d06f2026-07-17WarningsExact identifier
application number: M010
ndc (product): 68163-710
nighttime sleep aidDIPHENHYDRAMINE HCLAmazon.com Services LLCa8056e5f-e9d8-4555-9212-bf1fa3c154392026-07-16WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLAmerisource Bergen147adc14-ca7c-45f5-9925-ea569edbfe962026-07-09WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCL 25 MGHealth Pharma USA LLCd659f747-9790-8bd6-e053-2995a90ae7932026-07-07WarningsExact identifier
application number: M010
PharbedrylDIPHENHYDRAMINE HCLSt. Mary's Medical Park Pharmacy3ef18965-bafb-cc19-e063-6394a90af17d2026-06-29WarningsExact identifier
application number: M010
CalmCo Sleep AidDIPHENHYDRAMINE HCLCalmCo LLC552d0e50-a58c-8e47-e063-6394a90a8f7b2026-06-26WarningsExact identifier
application number: M010
Vicks ZzzQuil Night PainDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENThe Procter & Gamble Manufacturing Companya7cf8e2e-7aac-a1fa-e053-2a95a90a561a2026-06-26WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLBi-Mart1b40e794-089f-4546-8f8d-ba7016cd4e7f2026-06-22WarningsExact identifier
application number: M010
Sleep-AidDIPHENHYDRAMINE HCLRite Aid Corporation1a5668df-2bbc-4724-af39-19d30a8920f32026-06-22WarningsExact identifier
application number: M010
Sleep Aid Night TimeDIPHENHYDRAMINE HCLDOLGENCORP, LLC9f1e2e1f-d3e8-4c8a-9e3e-c2ab9e4c79e82026-06-16WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTopco Associates, LLC57a81e24-ef0d-4143-b266-71e2d4be76172026-06-16WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLCVS Pharmacy3710254e-6c3c-4044-9694-59703274cd0f2026-06-15WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLWal-Mart Stores Inccfddfdeb-701f-452d-876d-8003e6fcefe32026-06-15WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLFamily Dollar Services Inc2d63400b-43ae-4dd2-b917-3f65e02366b42026-06-08WarningsExact identifier
application number: M010
MantraMANTRA SLEEP AID WILD CHERRYMOREMED INC.316d11fe-a173-a1dd-e063-6394a90af4992026-05-21WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLTOPCO ASSOCIATES LLC9558cc42-d27d-42af-b0a7-44cad025165d2026-05-21WarningsExact identifier
application number: M010
Sleep Aid NightTimeDIPHENHYDRAMINE HCLWal-Mart Stores Incdac2a0b9-f851-467b-a39f-3560d42c96e22026-05-20WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNea3a51af-3025-497f-8cd7-e99391b0d06f5
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDea3a51af-3025-497f-8cd7-e99391b0d06f5
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYea3a51af-3025-497f-8cd7-e99391b0d06f5
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYea3a51af-3025-497f-8cd7-e99391b0d06f5
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYea3a51af-3025-497f-8cd7-e99391b0d06f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68163-710-08681630710081 BOTTLE, PLASTIC in 1 CARTON (68163-710-08) / 236 mL in 1 BOTTLE, PLASTIC2021-11-220000-00-00NoNoCurrent