FDA.reportPublic FDA data

OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)

Product NDC
87078-421
11-digit product format
870780421
Labeler code
87078
Product ID
87078-421_4157b5d8-b6fa-c9ce-e063-6394a90a784c
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
MEDWISE LIFESCIENCES INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-06
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

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
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)
Listing expiration
2026-12-31

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
4157e680-37ac-eb4c-e063-6394a90a2a99Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87078-421-52OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)5 mL in 1 POUCHSOLUTION51
87078-421-52OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)12 in 1 CARTONSOLUTION121

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 114 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Sinus Max Clear and CoolACETAMINOPHEN AND GUAIFENESINRB Health (US) LLC37de813a-54b7-672a-e063-6294a90a374e2025-06-18WarningsExact identifier
application number: M012
childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4a1aeb41-a8fa-4116-8068-e11acd608e582025-06-18WarningsExact identifier
application number: M012
NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIXACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATEDLil' Drug Store Products, Inc.37c768f5-dabd-22d0-e063-6394a90af9e52025-06-17WarningsExact identifier
application number: M012
DISCOUNT DRUG MART Childrens Allergy ChewableDIPHENHYDRAMINE HCLDISCOUNT DRUG MART51de95da-e8e8-48f0-9fa4-6191aa4a247b2025-06-16WarningsExact identifier
application number: M012
Halls CherryMENTHOLMondelez Global LLC5f4af8e8-8550-45c7-a199-694efac9e7be2025-06-16WarningsExact identifier
application number: M012
Halls Honey LemonMENTHOLMondelez Global LLC25eaae85-d516-40da-a472-70736ea2b75d2025-06-16WarningsExact identifier
application number: M012
Halls CherryMENTHOLMondelez Global LLCbad89968-22a7-4287-a57c-9e6206e574fe2025-06-16WarningsExact identifier
application number: M012
Herbal Throat DropsLEMON MINT HERBALMeijer, Inc.37dd58ad-95d1-568c-e063-6394a90a94332025-06-16WarningsExact identifier
application number: M012
topcare childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDETopco Associates LLC40a6a7e3-6ec9-4005-9406-9d5b044b3c212025-06-16WarningsExact identifier
application number: M012
Daytime Nighttime Sinus ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLTarget Corporation23f50b88-52c3-2029-e063-6394a90ac73e2025-06-14WarningsExact identifier
application number: M012
Cough Drops Dollar General Berries Flavor 25ctPECTINDollar General Corporationc53c19a9-5984-4b08-ae46-a53dc8bb7d742025-06-13WarningsExact identifier
application number: M012
Cough Drops Dollar General Strawberry Flavor 25ctPECTINDollar General Corporationd82034ca-b7fd-48c8-ab4a-8e1e564183242025-06-13WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLBelleview Biosciences1db57d86-39f0-f8ca-e063-6394a90a63972025-06-12WarningsExact identifier
application number: M012
TARGET Cold and Cough and Nighttime Value PackBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL,TARGET CORPORATIONce536313-7265-405c-88b7-f45e62781da52025-06-11WarningsExact identifier
application number: M012
Capron MaxDEXTROMETHORPHAN HBR AND PYRILAMINE MALEATECapital Pharmaceutical, LLC3756812b-f128-8946-e063-6294a90a59ba2025-06-11WarningsExact identifier
application number: M012
SAFETUSSIN Non Drowsy Cough plus chest congestionDEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES60311ca3-8544-417e-aa29-e9f65c6692ba2025-06-11WarningsExact identifier
application number: M012
Cold Max NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.e65d2815-6932-123c-e053-2a95a90a2cf92025-06-10WarningsExact identifier
application number: M012
Cold Head Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmerican Sales Company0cc66c6c-db26-4bb2-a97d-c4106210d70c2025-06-10WarningsExact identifier
application number: M012
Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL.N.K. International, Inc.75a9c736-bc7e-4b7f-84ea-9474a37508ec2025-06-10WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINKJD Pharma Private Limited8877bb8d-479f-4968-8033-5c269d449a462025-06-10WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN4157e680-37ac-eb4c-e063-6394a90a2a991
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD4157e680-37ac-eb4c-e063-6394a90a2a991
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY4157e680-37ac-eb4c-e063-6394a90a2a991
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY4157e680-37ac-eb4c-e063-6394a90a2a991
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY4157e680-37ac-eb4c-e063-6394a90a2a991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87078-421-528707804215212 POUCH in 1 CARTON (87078-421-52) / 5 mL in 1 POUCH12 pouch2025-10-17NoNoCurrent