FDA.reportPublic FDA data

allergy relief

Product NDC
59779-874
11-digit product format
597790874
Labeler code
59779
Product ID
59779-874_5cad0028-2e5f-4960-98fc-9e94b08be368
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-09-03
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59779-87459779-874-34DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59779-87459779-874-34DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
allergy relief
Brand name suffix
childrens
Listing expiration
2027-12-31

Active Ingredients#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
59779-874-26CVS Pharmacy, Inc. Children’s Allergy Relief Drug Facts
59779-874-26CVS Pharmacy, Inc. Children’s Allergy Relief Drug Facts
59779-874-26CVS Pharmacy, Inc. Children’s Allergy Relief Drug Facts
59779-874-34CVS Pharmacy, Inc. Children’s Allergy Relief Drug Facts
59779-874-34CVS Pharmacy, Inc. Children’s Allergy Relief Drug Facts
59779-874-34CVS Pharmacy, Inc. Children’s Allergy Relief Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-874-26allergy reliefchildrens1 in 1 CARTONSOLUTION16
59779-874-26allergy reliefchildrens118 mL in 1 BOTTLESOLUTION1186
59779-874-34allergy reliefchildrens1 in 1 CARTONSOLUTION16
59779-874-34allergy reliefchildrens236 mL in 1 BOTTLESOLUTION2366

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-874-26ML - Milliliter59779-8744cb4a87c-bcfb-4160-b09a-2fd30df77cc312018-02-20
59779-874-34ML - Milliliter59779-87418e840bb-3189-47a4-b0dc-65becdfa008312018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) LIQUID [CVS PHARMACY]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) LIQUID [CVS PHARMACY]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) LIQUID [CVS PHARMACY]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) LIQUID [CVS PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) LIQUID [CVS PHARMACY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) LIQUID [CVS PHARMACY]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) LIQUID [CVS PHARMACY]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) LIQUID [CVS PHARMACY]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) LIQUID [CVS PHARMACY]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) LIQUID [CVS PHARMACY]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) LIQUID [CVS PHARMACY]1
SORBITOLINACTIVE INGREDIENT506T60A25RALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) LIQUID [CVS PHARMACY]1
WATERINACTIVE INGREDIENT059QF0KO0RALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) LIQUID [CVS PHARMACY]1

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 135 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c62024-11-21WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mgDEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.028b025e-2dde-4bef-ba7b-61774e855b4b2024-11-21WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLC856cb3c3-8f32-4285-8c13-25f01779a31a2024-11-21WarningsExact identifier
application number: M012
Night Time Severe Cold and Flu ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC3375a059-2939-438e-92b5-a7f1952bbb222024-11-21WarningsExact identifier
application number: M012
NiteTime Cold/Flu, Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc9033bf94-f444-4488-b717-050d04dee3882024-11-21WarningsExact identifier
application number: M012
Day and Night Sinus Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores, Inc.4b554ce8-9a6a-444f-b5ea-63359bbc06532024-11-21WarningsExact identifier
application number: M012
Day Severe Cold and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores, Inc.7492b381-9eca-4b07-b356-63fdaea14f812024-11-21WarningsExact identifier
application number: M012
Severe sinus Congestion ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEFOODHOLD U.S.A., LLCe173bec9-14df-4535-a023-47d8cda8d4ec2024-11-21WarningsExact identifier
application number: M012
COLD FLU and SORE THROAT RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEFOODHOLD U.S.A., LLC1161e5dc-0677-4fb9-964f-971a508098b62024-11-21WarningsExact identifier
application number: M012
Night Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERetail Business Services, LLCfc8c70d6-6be5-4f12-84b0-125fc82149ec2024-11-21WarningsExact identifier
application number: M012
12 Hour Original Nasal DecongestantNASAL SPRAYWinCo Foods LLCb3b6065a-56da-45e9-b89d-f6553bc181c92024-11-21WarningsExact identifier
application number: M012
Family Wellness Oxymetazoline Sinus SevereOXYMETAZOLINEFAMILY DOLLAR (Family Wellness)13237d31-c60a-49f8-9b96-4414cf766a082024-11-21WarningsExact identifier
application number: M012
DayTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.5b55d1df-275b-40d8-bde3-fc43313b7eb32024-11-20WarningsExact identifier
application number: M012
Halls Green AppleMENTHOLMondelez Global LLC1bb8dcb2-c3a8-a64e-e063-6294a90ae4a22024-11-20WarningsExact identifier
application number: M012
Halls BlueberryMENTHOLMondelez Global LLC275a6935-ea44-486e-e063-6394a90ae19a2024-11-20WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYWalgreens Company234bd567-4e3c-419f-a000-fdfc28cafc8b2024-11-20WarningsExact identifier
application number: M012
NICE Assorted Cough DropsMENTHOLLeosons Overseas Corp96db0f37-41cc-1ebd-e053-2a95a90a32152024-11-19WarningsExact identifier
application number: M012
Nice Cherry Cough DropsMENTHOLLeosons Overseas Corp98e52604-6e41-6408-e053-2995a90a6bc82024-11-19WarningsExact identifier
application number: M012
NICE Citrus Cough DropsMENTHOLLeosons Overseas Corp96d9527d-9bf9-ce82-e053-2995a90aff0c2024-11-19WarningsExact identifier
application number: M012
NICE Menthol Cough DropsMENTHOLLeosons Overseas Corp96d77897-475c-482c-e053-2995a90a2da42024-11-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN8b539dc0-5487-4b11-babd-52bf341a89476
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD8b539dc0-5487-4b11-babd-52bf341a89476
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY8b539dc0-5487-4b11-babd-52bf341a89476
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY8b539dc0-5487-4b11-babd-52bf341a89476
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY8b539dc0-5487-4b11-babd-52bf341a89476

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-874-26597790874261 BOTTLE in 1 CARTON (59779-874-26) / 118 mL in 1 BOTTLE1 bottle2015-09-030000-00-00NoNoCurrent
59779-874-34597790874341 BOTTLE in 1 CARTON (59779-874-34) > 236 mL in 1 BOTTLE1 bottle2015-09-030000-00-00NoNoCurrent