FDA.reportPublic FDA data

Allergy Relief

Product NDC
49035-901
11-digit product format
490350901
Labeler code
49035
Product ID
49035-901_a627efa4-b920-4b38-9b2d-e08fc3ec0087
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Wal-Mart Stores Inc
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

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
1049909Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c88e93d4-66b6-4327-b9e5-0e0a95a18d66Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-901-08Allergy Relief2 in 1 CARTONCAPSULE218
49035-901-08Allergy Relief12 in 1 BLISTER PACKCAPSULE1218
49035-901-12Allergy Relief100 in 1 BOTTLE, PLASTICCAPSULE10018
49035-901-12Allergy Relief1 in 1 CARTONCAPSULE118
49035-901-42Allergy Relief12 in 1 BLISTER PACKCAPSULE1218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-901-12EA - Each49035-901a478687b-ed82-4502-bff1-1547021160c012017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8ALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
GELATININACTIVE INGREDIENT2G86QN327LALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-901ALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]16Current NDC, Legacy NDC, 5 package rows20240623_c88e93d4-66b6-4327-b9e5-0e0a95a18d66.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 139 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Poly-Vent IRGUAIFENESIN AND PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.ce0d8c45-446a-4df4-a36b-5000ba69d30d2024-11-09WarningsExact identifier
application number: M012
basic care tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmazon.com Services LLC306d5914-03ed-410a-9345-c54ba604e9912024-11-09WarningsExact identifier
application number: M012
care one nasal originalOXYMETAZOLINE HYDROCHLORIDEAmerican Sales Companya0c35e06-c9e9-438e-8224-d4760b6e2aff2024-11-09WarningsExact identifier
application number: M012
adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Company34174507-cf2e-4ed4-85ec-f915d4b910df2024-11-08WarningsExact identifier
application number: M012
Childrens Benadryl ChewablesDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCb08f71d8-a06c-41ba-8ed1-fbc41dbc19192024-11-08WarningsExact identifier
application number: M012
SUDAFED PE SINUS CONGESTIONDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCa38fdfb8-db89-487f-9b68-aa9152b91f5f2024-11-08WarningsExact identifier
application number: M012
SUDAFED Sinus CongestionPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLCc05d7e27-6821-468f-b27d-9c0b02a07b0f2024-11-08WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC2884d2dc-2d4a-4ca6-ab73-688a80b428eb2024-11-08WarningsExact identifier
application number: M012
Extra Strength TYLENOL Cold plus Flu Multi-Action Day/NightACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND CHLORPHENIRAMINE MALEATEKenvue Brands LLC712ba011-79aa-469b-9f0f-04a0b4b705bd2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC8538c291-9ce9-4866-b268-f4cbdb52f5bd2024-11-08WarningsExact identifier
application number: M012
Childrens Sudafed Nasal DecongestantPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLC52e9307b-ad38-4f65-bb2f-4fa262e820102024-11-08WarningsExact identifier
application number: M012
Benadryl Allergy Plus CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC685b51d3-cc25-47b2-ac8a-368924f431372024-11-08WarningsExact identifier
application number: M012
Sudafed PE Sinus Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC60183922-bfd3-4377-884a-51b2f0a4c93a2024-11-08WarningsExact identifier
application number: M012
Sudafed PE Sinus CongestionPHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC2ca08917-1a75-4365-8520-c083e6a4225a2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Head Congestion Plus MucusACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCf0739186-41b9-4761-adf7-08101b30a18e2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Head Congestion Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC1e528f78-0ced-4a06-935a-84056c9217272024-11-08WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPackACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC657a1e59-104c-4152-b2c9-00a8b82dc78e2024-11-08WarningsExact identifier
application number: M012
Tylenol Cold plus Flu Severe and Tylenol Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC47c61858-72ce-409b-a3af-a63620cf7d132024-11-08WarningsExact identifier
application number: M012
Childrens Benadryl Allergy Plus CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCb8b75904-3806-4258-89c1-d6ff486ed41c2024-11-08WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-PackACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC464de5de-0e7a-41d6-875f-dd0e5fe7893c2024-11-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNc88e93d4-66b6-4327-b9e5-0e0a95a18d6618
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDc88e93d4-66b6-4327-b9e5-0e0a95a18d6618

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-901-08490350901082 BLISTER PACK in 1 CARTON (49035-901-08) / 12 CAPSULE in 1 BLISTER PACK2 blister pack1990-03-150000-00-00NoNoCurrent
49035-901-12490350901121 BOTTLE, PLASTIC in 1 CARTON (49035-901-12) / 100 CAPSULE in 1 BOTTLE, PLASTIC1990-03-150000-00-00NoNoCurrent
49035-901-424903509014212 CAPSULE in 1 BLISTER PACK (49035-901-42) 12 capsule1990-03-150000-00-00NoNoCurrent