FDA.reportPublic FDA data

Diphenhydramine

Product NDC
57344-090
11-digit product format
573440090
Labeler code
57344
Product ID
57344-090_284d200c-7ba4-d545-e063-6394a90a4d51
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
AAA Pharmaceutical, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-04-13
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
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
Diphenhydramine
Listing expiration
2026-12-31

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
76724432-ff3c-404f-ba1f-5af68e3ab8c4Available 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
57344-090-02Diphenhydramine4 in 1 CARTONTABLET, COATED45
57344-090-02Diphenhydramine12 in 1 BLISTER PACKTABLET, COATED125
57344-090-03Diphenhydramine1 in 1 CARTONTABLET, COATED15
57344-090-03Diphenhydramine100 in 1 BOTTLE, PLASTICTABLET, COATED1005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JDIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KDIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57344-090DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.]5Current NDC, Legacy NDC, 4 package rows20241204_76724432-ff3c-404f-ba1f-5af68e3ab8c4.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 31 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Nightshift Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC09fdf96f-345f-43f2-9f0f-8303ac70849e2026-05-13WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Night Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC2ce31244-9c6c-b7dd-e063-6394a90a31a82026-05-13WarningsExact identifier
application number: M012
equate daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc2ac53cc7-000f-41fd-b799-4e6d6886fe622026-05-13WarningsExact identifier
application number: M012
nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Inc2201d5c0-bd51-47a7-9775-916b185736232026-05-13WarningsExact identifier
application number: M012
topcare nite time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETopco Associates LLCf868e4a0-e9fb-4e6a-9984-29a2182462412026-05-13WarningsExact identifier
application number: M012
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEMeijer Distribution Inc582fa36b-6d0c-4ff3-80ab-6e0da4b209e42026-05-13WarningsExact identifier
application number: M012
SudoGestPSEUDOEPHEDRINE HYDROCHLORIDEMajor Pharmaceuticals78faa497-6743-b85b-e053-2a91aa0ae8222026-05-12WarningsExact identifier
application number: M012
Allergy Relief mini SoftgelsDIPHENHYDRAMINE HCI 25 MGCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdf1c620b-ff59-4126-99a5-1d6750888f2b2026-05-12WarningsExact identifier
application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC14c56f3d-67fd-45ef-a16b-f276047228832026-05-12WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare, LLC.51a4195b-8776-964c-e063-6294a90aa0752026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and Flu and Mucinex Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3ba3548e-85e7-b4a6-e063-6394a90af84d2026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCfe7eeb71-e219-4c84-ac06-98c3a40b14dc2026-05-12WarningsExact identifier
application number: M012
Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51a45db8-2bee-6fd0-e063-6394a90ab5872026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC19da539e-7b57-41d7-aad5-fc89a6705e202026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC8a790eeb-7d7d-4a94-9103-6ed09c04d5962026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCdbdafbb4-f3c9-4042-b867-db4d06dc3d612026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd03ef2fd-1a08-42c0-b69d-fd4e4285ccd32026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC29571047-4c4b-44ca-8726-57c28308e8cf2026-05-12WarningsExact identifier
application number: M012
Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCc746953f-4b7d-4e2a-9b85-96bd6901f5172026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC2ef9d5de-e99e-4398-bf97-c7bef94498fa2026-05-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN76724432-ff3c-404f-ba1f-5af68e3ab8c45
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD76724432-ff3c-404f-ba1f-5af68e3ab8c45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57344-090-02573440090024 BLISTER PACK in 1 CARTON (57344-090-02) / 12 TABLET, COATED in 1 BLISTER PACK4 blister pack2012-04-130000-00-00NoNoCurrent
57344-090-03573440090031 BOTTLE, PLASTIC in 1 CARTON (57344-090-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2017-11-270000-00-00NoNoCurrent