FDA.reportPublic FDA data

dg health allergy

Product NDC
55910-379
11-digit product format
559100379
Labeler code
55910
Product ID
55910-379_578b57dc-eb5a-44be-98ed-f6b82f2c6a0b
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Dolgencorp, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-01-29
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
dg health allergy
Brand name suffix
childrens
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
71445443-34bd-4d8c-b9c8-e7c3b8d4c832Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-379-262024-01-30C16284748780-11030e365-35b3-111a-e063-dadaa90a10e2Dolgencorp, LLC Children's Allergy Drug Facts
55910-379-342024-01-30C16284748780-11030e365-35b3-111a-e063-dadaa90a10e2Dolgencorp, LLC Children's Allergy Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-379-26dg health allergychildrens118 mL in 1 BOTTLESOLUTION1189
55910-379-26dg health allergychildrens1 in 1 CARTONSOLUTION19
55910-379-34dg health allergychildrens237 mL in 1 BOTTLESOLUTION2379
55910-379-34dg health allergychildrens1 in 1 CARTONSOLUTION19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DG HEALTH ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [DOLGENCORP, LLC]4
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDG HEALTH ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [DOLGENCORP, LLC]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDG HEALTH ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [DOLGENCORP, LLC]4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDG HEALTH ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [DOLGENCORP, LLC]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADG HEALTH ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [DOLGENCORP, LLC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDG HEALTH ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [DOLGENCORP, LLC]4
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SDG HEALTH ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [DOLGENCORP, LLC]4
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2DG HEALTH ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [DOLGENCORP, LLC]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDG HEALTH ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [DOLGENCORP, LLC]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDG HEALTH ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [DOLGENCORP, LLC]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDG HEALTH ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [DOLGENCORP, LLC]4
SORBITOLINACTIVE INGREDIENT506T60A25RDG HEALTH ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [DOLGENCORP, LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RDG HEALTH ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [DOLGENCORP, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-379DG HEALTH ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [DOLGENCORP, LLC]9Current NDC, Legacy NDC, 4 package rows20240724_71445443-34bd-4d8c-b9c8-e7c3b8d4c832.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 102 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AXIV DayTime - NightTime 48 SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC1320e243-344f-98ed-e063-6294a90a00922025-09-17WarningsExact identifier
application number: M012
AXIV Sinus Severe MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDEVIVUNT PHARMA LLC13245298-8b78-e177-e063-6294a90a6bec2025-09-17WarningsExact identifier
application number: M012
GoodSense Tussin CF Multi-Symptom Cold, RaspberryDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.3f05cf84-d485-7688-e063-6394a90ae7402025-09-17WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)5d7466b4-fdb7-432b-880d-e7aa4a4acbda2025-09-17WarningsExact identifier
application number: M012
allergy relief ChildrensDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFIe34d8bf5-e12e-453c-93ea-9c7988c4f13d2025-09-16WarningsExact identifier
application number: M012
DayTime Cold Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHarris Teeter, LLC67beb9f6-4e0a-4f7b-b50a-4bcd3a01354f2025-09-16WarningsExact identifier
application number: M012
DOMETUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEDomel Laboratories3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe2025-09-16WarningsExact identifier
application number: M012
CareOne Severe Congestion NasalOXYMETAZOLINE HYDROCHLORIDEAmerican Sales Companyd1dba68b-c4e1-4afc-9aee-6a51341b89f52025-09-16WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFSA Store Inc. (Caring Mills)e69ef8dc-09d2-46de-aebf-ba735f4cc7ea2025-09-16WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Lemon FlavorMENTHOL HONEY LEMON FLAVORCVS Pharmacy3ea9a1f2-75b3-c67a-e063-6294a90a8caf2025-09-13WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Lemon FlavorMENTHOL HONEY LEMON FLAVORCVS Pharmacy3eab4cf9-6fdc-a6fb-e063-6394a90a86332025-09-13WarningsExact identifier
application number: M012
COLD AND FLU DAYTIME-NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORP9de9fab3-890a-158d-e053-2a95a90af4232025-09-13WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPrecision Dose, Inc.4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea42025-09-12WarningsExact identifier
application number: M012
Nasal Spray, Circle KOXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTIONLil' Drug Store Products, Inc.3ea06e88-a2c6-621b-e063-6294a90a10752025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHarris Teeter, LLCa0090dc6-0fe5-4ab2-a2cf-6ed19892f3632025-09-12WarningsExact identifier
application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCICVS Pharmacyebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e2025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFSA Store Inc. (Caring Mills)8d7bb31b-a47d-4252-a0a7-79d286179fb92025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)150e5c3a-7c86-4b66-af30-a376df6974012025-09-12WarningsExact identifier
application number: M012
SEVERE COUGH COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED67f8d405-a2ad-4ade-93b4-9b09a0d81d8e2025-09-11WarningsExact identifier
application number: M012
equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.3862aaa5-2281-e8f9-e063-6294a90a0f7e2025-09-09WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN71445443-34bd-4d8c-b9c8-e7c3b8d4c8329
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD71445443-34bd-4d8c-b9c8-e7c3b8d4c8329
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY71445443-34bd-4d8c-b9c8-e7c3b8d4c8329
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY71445443-34bd-4d8c-b9c8-e7c3b8d4c8329
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY71445443-34bd-4d8c-b9c8-e7c3b8d4c8329

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-379-26559100379261 BOTTLE in 1 CARTON (55910-379-26) / 118 mL in 1 BOTTLE1 bottle2010-01-290000-00-00NoNoCurrent
55910-379-34559100379341 BOTTLE in 1 CARTON (55910-379-34) / 237 mL in 1 BOTTLE1 bottle2021-01-250000-00-00NoNoCurrent