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_f8611e9e-6741-46f4-ac4d-612b50799110
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
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
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 4 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep AidDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI6c9b7576-428a-4884-8331-bb312c9046bd2026-04-01WarningsExact identifier
application number: M010
Calmco Sleep AidDIPHENHYDRAMINE HCLCalmCo LLC471d4c70-813a-19de-e063-6394a90aeb252026-03-31WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLThe Kroger Co.0db543bb-c6c3-4370-a70c-e1652781fd7d2026-03-25WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCL 50MGGrocery Outlet57a751e9-d8b6-4527-8537-bc4be718f5ec2026-03-17WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWalgreen Companydf7a43d1-83a7-4e86-baef-4b9d1ebf0dbb2026-03-16WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEGrocery Outlet, Inc.4454df6a-931f-3f03-e063-6294a90afe732026-03-14WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLCardinal Health 110, LLC. DBA Leader1d73e966-aa4a-40a0-b42a-fda8e500756e2026-03-13WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWalgreensea1b5ec1-3c8e-437d-8e37-f38ab66d9f782026-03-13WarningsExact identifier
application number: M010
ZzzQuil Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyad4babdb-d98d-420e-b8b0-9a5368c89a442026-03-12WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8dc17b5d-1cf7-44d2-9e78-d2c6952c7d202026-03-11WarningsExact identifier
application number: M010
sleep aidDIPHENHYDRAMINE HCLRite Aid Corporationbdfd7d87-2b54-4c29-ba69-aad0fab682e72026-03-11WarningsExact identifier
application number: M010
ZzzQuil Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company1d608c94-1651-f318-e063-6294a90aa11e2026-03-05WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWal-Mart Stores Inc5ef35ab9-b6e8-4c88-a623-35ac9d6bd3592026-03-05WarningsExact identifier
application number: M010
ZzzQuil Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companye441c952-cd48-4159-ada2-271ca75416002026-02-20WarningsExact identifier
application number: M010
Vicks ZzzQuil NIGHT PAIN NIGHTTIME SLEEP-AID PAIN RELIEVERDIPHENHYDRAMINE HCL, ACETAMINOPHENThe Procter & Gamble Manufacturing Company065d760b-70a5-3e26-e063-6394a90a48cd2026-02-20WarningsExact identifier
application number: M010
Sleep-AidDIPHENHYDRAMINE HCLWALMART INC. (see also Equate)84c37f4d-60f6-490e-ba8b-47d1257fa6f82026-02-13WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLP & L Development, LLC59c063ad-6ea3-4f1d-a20e-5e5e062a90982026-02-10WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLWinCo Foods, LLCf446e56f-c664-4092-8712-aa3f204172f82026-02-02WarningsExact identifier
application number: M010
Sleep Aid Night TimeDIPHENHYDRAMINE HCLDOLGENCORP, LLCd805fab3-9dca-497f-bdc6-c8a7b17361092026-01-27WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0e45d0e8-3741-7cee-e063-6394a90a2de52026-01-27WarningsExact 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