FDA.reportPublic FDA data

Childrens Allergy Relief

Product NDC
59779-585
11-digit product format
597790585
Labeler code
59779
Product ID
59779-585_482f45fe-63a5-42a8-bf92-1d7744878c73
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-03-20
Marketing end
2028-01-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
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
Childrens Allergy Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/1

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
1049900Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8296049c-72fc-4200-9d45-c8e377314cf2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-585-07Childrens Allergy Relief6 in 1 CARTONTABLET, CHEWABLE620
59779-585-07Childrens Allergy Relief6 in 1 BLISTER PACKTABLET, CHEWABLE620
59779-585-44Childrens Allergy Relief3 in 1 CARTONTABLET, CHEWABLE320
59779-585-44Childrens Allergy Relief6 in 1 BLISTER PACKTABLET, CHEWABLE620

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-585-07EA - Each59779-58558858d83-af0a-43c1-9762-eb3ac1b7383312021-09-07
59779-585-44EA - Each59779-585dc6ff8c7-cfef-419c-92d4-ccad937207ac12017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
DEXTRATESINACTIVE INGREDIENTG263MI44RUCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
GRAPEINACTIVE INGREDIENT6X543N684KCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
MANNITOLINACTIVE INGREDIENT3OWL53L36ACHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-585CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [CVS PHARMACY]20Current NDC, Legacy NDC, 4 package rows20250430_8296049c-72fc-4200-9d45-c8e377314cf2.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 132 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLD AND FLU DAYTIME SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORP9de99931-31ef-79e2-e053-2a95a90a98ad2024-12-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETopCo Associates LLC3ef6d155-b95b-4b30-87a8-8ed811b1520f2024-12-03WarningsExact identifier
application number: M012
Sinus plus HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDETOPCAREa1b2b16d-c767-2945-e053-2995a90a48342024-12-03WarningsExact identifier
application number: M012
Sinus Congestion and Pain SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETopCarefa9b2748-0474-4a39-a2b8-bb6f0678c1d12024-12-03WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCa9640e09-369c-3c55-e053-2a95a90aebd52024-12-03WarningsExact identifier
application number: M012
Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCec7e5e2e-23c7-32ae-e053-2995a90a12512024-12-03WarningsExact identifier
application number: M012
COLD AND FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCAREcbb179c8-31fb-4a3a-9f23-4024350f8b7f2024-12-03WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCa96431a0-b05d-4812-e053-2a95a90a5af62024-12-03WarningsExact identifier
application number: M012
Cold Max NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLCaa0d6762-b803-4630-8f74-780b7ea9acff2024-12-03WarningsExact identifier
application number: M012
Cold plus Head CongestionACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCec7e5e2e-23c5-32ae-e053-2995a90a12512024-12-03WarningsExact identifier
application number: M012
Cold Plus Head Congestion Day and NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLC898eb1c7-395a-4845-9d0a-719fc78d86b72024-12-03WarningsExact identifier
application number: M012
Cold Plus Head Congestion NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLC7854c1fd-b5fc-477d-a79e-ff006ebf6fe52024-12-03WarningsExact identifier
application number: M012
Cold and Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLCe07d880b-a12a-4e5e-94c0-bd36bcfe738c2024-12-03WarningsExact identifier
application number: M012
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCAREbd0a3679-1f7c-4c41-e053-2995a90a8fcb2024-12-03WarningsExact identifier
application number: M012
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCbd09e4f3-3211-8c08-e053-2a95a90a73f92024-12-03WarningsExact identifier
application number: M012
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HClACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb373a3a8-68c4-0187-e053-2995a90aad622024-12-03WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All In OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCAREa1b281ec-fd42-963c-e053-2a95a90a4b712024-12-03WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCb3366ad4-5ef4-eb70-e053-2995a90acf332024-12-03WarningsExact identifier
application number: M012
Meijer Medicated Chest Rub, 3.53 oz. LavenderMENTHOL, CAMPHOR, EUCALYPTUS OILMeijer Distribution22516f25-b8aa-7511-e063-6394a90a61252024-12-03WarningsExact identifier
application number: M012
Tenalif ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cd9513-1a42-e990-e063-6294a90a57df2024-12-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049900diphenhydrAMINE HCl 12.5 MG Chewable TabletPSN8296049c-72fc-4200-9d45-c8e377314cf220
1049900diphenhydramine hydrochloride 12.5 MG Chewable TabletSCD8296049c-72fc-4200-9d45-c8e377314cf220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-585-07597790585076 BLISTER PACK in 1 CARTON (59779-585-07) / 6 TABLET, CHEWABLE in 1 BLISTER PACK6 blister pack2009-03-202028-01-31NoNoCurrent
59779-585-44597790585443 BLISTER PACK in 1 CARTON (59779-585-44) / 6 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2009-03-202028-01-31NoNoCurrent