FDA.reportPublic FDA data

Allergy Relief

Product NDC
42507-290
11-digit product format
425070290
Labeler code
42507
Product ID
42507-290_48494a07-2a50-2d2a-e063-6294a90a6570
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
HYVEE INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-22
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
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e608643-1a74-b474-e063-6294a90ad2e0Available 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
42507-290-01Allergy Relief12 in 1 BLISTER PACKTABLET, COATED123
42507-290-01Allergy Relief2 in 1 CARTONTABLET, COATED23
42507-290-03Allergy Relief1 in 1 CARTONTABLET, COATED13
42507-290-03Allergy Relief100 in 1 BOTTLE, PLASTICTABLET, COATED1003
42507-290-05Allergy Relief400 in 1 BOTTLE, PLASTICTABLET, COATED4003

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 141 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength TYLENOL Severe Cough Plus Sore Throat NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE.Kenvue Brands LLCf81d924e-10e9-0e9d-e053-6294a90a2ddf2024-11-07WarningsExact identifier
application number: M012
Childrens TYLENOL COLD Plus FLUACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC8b516736-86ac-47cb-a0ec-038d4c3a00202024-11-07WarningsExact identifier
application number: M012
Tylenol Cold plus Flu plus Cough NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCe85e5eb9-3ecf-4784-999e-111e38e306f52024-11-07WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCef8a846d-4b29-4fd8-a683-fada04d0a2b92024-11-07WarningsExact identifier
application number: M012
Childrens TYLENOL COLD Plus FLUACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC9761c807-75a1-4498-a8c6-1f2b1c9ffde62024-11-07WarningsExact identifier
application number: M012
TYLENOL Cold Plus Mucus SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC24ac94e8-b223-424e-bcd2-9c027c8ff9ed2024-11-07WarningsExact identifier
application number: M012
PrimateneEPHEDRINE HYDROCHLORIDEFoundation Consumer Brands2170f081-c03f-47e8-bc63-4052c5e653fa2024-11-07WarningsExact identifier
application number: M012
Rompe Pecho Max Multi SymptomsACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESINEFFICIENT LABORATORIES INC938e4e47-d2d9-4b0d-bf88-e9f41b5019452024-11-07WarningsExact identifier
application number: M012
topcare sinus nasalOXYMETAZOLINE HYDROCHLORIDETopco Associates LLCca1fefed-e9d7-430a-9da4-972b1a6fb7862024-11-07WarningsExact identifier
application number: M012
Leader Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderdd82a389-9ec5-4b3f-a9ea-1a56871ebd172024-11-07WarningsExact identifier
application number: M012
topcare day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC1a8e2e03-e11b-4da1-945b-e2caadea72432024-11-07WarningsExact identifier
application number: M012
SUDOGEST NASAL DECONGESTANTPSEUDOEPHEDRINE HCLA-S Medication Solutions09feb5f0-c22d-4a1b-97a0-d5767e5f77302024-11-07WarningsExact identifier
application number: M012
up and up childrens allergy meltsDIPHENHYDRAMINE HCLTarget Corporationf98d1d54-8e11-4bb1-825a-ab5447d378472024-11-07WarningsExact identifier
application number: M012
good sense severe day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company44130a1b-63cc-42ac-9590-fdf21a12d1642024-11-07WarningsExact identifier
application number: M012
foster and thrive daytime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrategic Sourcing Services LLCa5ff1134-8985-4585-8e61-a5fd5f60afeb2024-11-07WarningsExact identifier
application number: M012
basic care daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC50528d29-ce8c-4efb-a86c-17246b017db02024-11-07WarningsExact identifier
application number: M012
cooling severe daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS Pharmacyd4a21760-b2bd-4e26-bff0-6fc1b05d26b32024-11-07WarningsExact identifier
application number: M012
dg health day time severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLC60870311-3234-44ba-95dd-09cf4ea3d5082024-11-07WarningsExact identifier
application number: M012
adult dm max cough and chest congestionDEXTROMETHORPHAN HBR, GUAIFENESINMeijer Distribution Inc3a6855c1-da6d-4fa9-81fe-d2e61355989f2024-11-06WarningsExact identifier
application number: M012
oxymetazoline hclOXYMETAZOLINE HYDROCHLORIDEA-S Medication Solutionse51dfb62-40d0-4bec-9574-90057cb35bcc2024-11-06WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN3e608643-1a74-b474-e063-6294a90ad2e03
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD3e608643-1a74-b474-e063-6294a90ad2e03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-290-01425070290012 BLISTER PACK in 1 CARTON (42507-290-01) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2025-10-22NoNoCurrent
42507-290-03425070290031 BOTTLE, PLASTIC in 1 CARTON (42507-290-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2026-01-13NoNoCurrent
42507-290-0542507029005400 TABLET, COATED in 1 BOTTLE, PLASTIC (42507-290-05) 2026-01-13NoNoCurrent