FDA.reportPublic FDA data

Allergy Relief

Product NDC
55301-190
11-digit product format
553010190
Labeler code
55301
Product ID
55301-190_b9c2cd25-1050-468f-8241-d671130acce4
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-03-15
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
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
Allergy Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55301-190-08Allergy Relief2 in 1 CARTONCAPSULE217
55301-190-08Allergy Relief12 in 1 BLISTER PACKCAPSULE1217

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8ALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
GELATININACTIVE INGREDIENT2G86QN327LALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-190ALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]16Current NDC, Legacy NDC, 2 package rows20250215_97ed70a0-b692-4c12-90d6-72b3c87e554c.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 92 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEVERITYRX, LLC42a0e577-a1b6-2c16-e063-6294a90af8e32025-11-02WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corpc296efd0-5030-4a26-a9b0-e66423d995dc2025-10-31WarningsExact identifier
application number: M012
Daytime Cold and Flu Max Maximum Strength SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTopco Associates, LLCf7ebe482-cb22-4517-8463-3432cf60071d2025-10-31WarningsExact identifier
application number: M012
Nighttime Cold and Flu Max SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates, LLC787bff76-0ee2-4e7e-b908-876e4a3e3bfc2025-10-31WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLTrader Joe's Company647dadae-f37a-8399-e053-2991aa0aedb32025-10-31WarningsExact identifier
application number: M012
Family Care SalineSODIUM CHLORIDEUnited Exchange Corp.06737393-d4ae-3e7b-e063-6394a90ac19f2025-10-31WarningsExact identifier
application number: M012
QUALITY CHOICE Maximum Strength Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.40416ff5-06e1-97dd-e063-6394a90a20462025-10-30WarningsExact identifier
application number: M012
Robitussin Maximum Strength Nighttime Cough DMDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHaleon US Holdings LLC44feee2f-25bc-48d4-8e13-db1d9daaaa902025-10-30WarningsExact identifier
application number: M012
Robitussin Day and Night Cough Relief DM MaxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCb3d02c91-8f79-4eb4-a378-1072474c572c2025-10-30WarningsExact identifier
application number: M012
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCf1d022dd-c2ca-497f-87d5-9ef3e20e8ea72025-10-30WarningsExact identifier
application number: M012
EndalTRIPROLIDINE HCL, DEXTROMETHORPHAN HBRPoly Pharmaceuticals, Inc.fc5401e2-ed65-72e7-e053-6294a90a81f32025-10-30WarningsExact identifier
application number: M012
daytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPublix Super Markets Incc7cef266-46fc-49ab-a2e7-54fc562986592025-10-30WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDESAM'S WEST INC16592ad7-b7cb-0837-e063-6394a90ae0592025-10-29WarningsExact identifier
application number: M012
Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCLSAFEWAY013b94a1-26c7-4371-981a-d1b9d7fd1c982025-10-29WarningsExact identifier
application number: M012
Better LivingPHENYLEPHRINE HYDROCHLORIDEBETTER LIVING BRANDS LLCaea0db7f-e01a-4d8e-9c20-4a5ef4a905d12025-10-29WarningsExact identifier
application number: M012
AXIM DayTime - Night Time 72 SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEVIVUNT PHARMA LLCde9eb2d5-ba51-4637-e053-2995a90a04512025-10-29WarningsExact identifier
application number: M012
Dollar General Vapor SteamCAMPHOR (SYNTHETIC)DOLGENCORP, LLC86d0f3ac-1359-c2f9-e053-2a91aa0a35d02025-10-29WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLStrategic Sourcing Services LLC5d628b09-c257-4369-8ddb-47554d83c0d82025-10-29WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWal-Mart Stores,Inc.,a748d5ab-901c-47bb-8437-997542ecebfe2025-10-28WarningsExact identifier
application number: M012
Nighttime Childrens Multi Symptoms Cold and Cough Multi-Symptom ReliefCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEWAL-MART STORES,INC.68a68574-0fcb-4569-be57-d9aee5f62bea2025-10-28WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN97ed70a0-b692-4c12-90d6-72b3c87e554c17
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD97ed70a0-b692-4c12-90d6-72b3c87e554c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-190-08553010190082 BLISTER PACK in 1 CARTON (55301-190-08) / 12 CAPSULE in 1 BLISTER PACK2 blister pack1990-03-150000-00-00NoNoCurrent