FDA.reportPublic FDA data

Benadryl Ultratabs

Product NDC
67751-166
11-digit product format
677510166
Labeler code
67751
Product ID
67751-166_2385ad34-3763-390b-e063-6394a90a12fd
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-09-22
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
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
Benadryl Ultratabs
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049630Internal RxNorm lookup
1049632Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
76433e3c-142c-4704-8b2b-d602f008c377Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
67751-166-012023-03-15Benadryl Ultratabs
67751-166-022023-03-15Benadryl Ultratabs
67751-166-012023-01-30Benadryl Ultratabs
67751-166-022023-01-30Benadryl Ultratabs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-166-01Benadryl Ultratabs2 in 1 POUCHTABLET, FILM COATED24
67751-166-01Benadryl Ultratabs1 in 1 CARTONTABLET, FILM COATED14
67751-166-02Benadryl Ultratabs1 in 1 CARTONTABLET, FILM COATED14
67751-166-02Benadryl Ultratabs4 in 1 POUCHTABLET, FILM COATED44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-166BENADRYL ULTRATABS (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.]4Current NDC, Legacy NDC, 4 package rows20241004_76433e3c-142c-4704-8b2b-d602f008c377.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 35 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Childrens Cough and Chest Congestion Mini-Melts Orange CremeDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC66543190-1d3d-4259-ae73-d366ecbf9e522026-05-12WarningsExact identifier
application number: M012
basic care daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC612719a9-fa2e-4c40-8f35-a399aeaafecc2026-05-12WarningsExact identifier
application number: M012
Sinus Pressure and Pain Daytime Nighttime Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company3cac44ad-1835-487e-b6d0-1483d724bb5e2026-05-12WarningsExact identifier
application number: M012
GUAIFENESIN DMGUAIFENESIN AND DEXTROMETHORPHANCardinal Health 107, LLC9cfb1abb-98c4-4e90-8dd7-fcffc112f9882026-05-12WarningsExact identifier
application number: M012
Nasal Decongestant PE and Pain Relief Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLWinCo Foods, LLCfab51b36-1c2e-4c97-932c-dacfaf55935a2026-05-11WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINWalgreen Companycad5da8c-65a6-44c4-a4c7-38f2c7fe43aa2026-05-11WarningsExact identifier
application number: M012
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
application number: M012
Device - NebuClear MD Hand-held Rubber Bulb NebulizerDEVICE - HAND-HELD RUBBER BULB NEBULIZERBlue Echo Care LLC43e0a646-be57-1024-e063-6394a90a43e42026-05-11WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED1efd1778-7ab1-4797-98c5-4637940ee3ec2026-05-11WarningsExact identifier
application number: M012
DayTime High Blood Pressure Cold and Flu Relief Liquid filled SoftgelsACETAMINOPHEN,DEXTROMETHROPHAN HBRAptaPharma Inc.0380035e-44d5-44ea-9d1c-d57a1de651882026-05-10WarningsExact identifier
application number: M012
Night Time Cold and Flu relief liquid filled softgelsACETAMINOPHEN,DEXTROMETHROPHAN HBR,DOXYLAMINE SUCCINATEAptaPharma Inc.d61e2186-8b59-45f9-96ec-83430a0fe0cb2026-05-10WarningsExact identifier
application number: M012
Maximum Strength Tussin DM Liquid filled SoftgelsDEXTROMETHORPHAN HBR, GUAIFENESINAptaPharma Inc.39ad6cc9-d2b0-4b4a-8aa3-977905c9e6f12026-05-10WarningsExact identifier
application number: M012
Day-Time Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAptaPharma Inc.c0dc613c-7f4e-4733-b2b6-6ba20e8fb83c2026-05-10WarningsExact identifier
application number: M012
Daytime Cold and Flu Relief Liquid Filled SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAptaPharma Inc.c078efb5-d30e-4dd1-a600-6e827390df762026-05-10WarningsExact identifier
application number: M012
DM Max CONGESTION and COUGHDEXTROMETHORPHAN HBR, GUAIFENESINDeMoulas Market Basketb12e26b2-79e4-45a5-9a90-4630f92457d02026-05-09WarningsExact identifier
application number: M012
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWalgreen Companyfac55d76-457f-4258-9cc8-6edae539cada2026-05-08WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHyVee Inc5a0ef8ae-f6d5-4388-b4da-6b7f025160b22026-05-08WarningsExact identifier
application number: M012
Halls Variety Pack Mentholyptus Honey Lemon CherryMENTHOLMondelez Global LLC512a9a2e-6160-80d1-e063-6394a90aeff02026-05-08WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5150ff85-85bb-9cd9-e063-6294a90a11442026-05-08WarningsExact identifier
application number: M012
Dr. Simi Children s CoughDEXTROMETHORPHAN HBR, GUAIFENESINFarmacias De Similares TX LLC5151740a-8270-7bb5-e063-6294a90ae3872026-05-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049632Benadryl 25 MG Oral TabletPSN76433e3c-142c-4704-8b2b-d602f008c3774
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN76433e3c-142c-4704-8b2b-d602f008c3774
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBD76433e3c-142c-4704-8b2b-d602f008c3774
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD76433e3c-142c-4704-8b2b-d602f008c3774
1049632Benadryl 25 MG Oral TabletSY76433e3c-142c-4704-8b2b-d602f008c3774
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSY76433e3c-142c-4704-8b2b-d602f008c3774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-166-01677510166011 POUCH in 1 CARTON (67751-166-01) / 2 TABLET, FILM COATED in 1 POUCH1 pouch2016-09-220000-00-00NoNoCurrent
67751-166-02677510166021 POUCH in 1 CARTON (67751-166-02) / 4 TABLET, FILM COATED in 1 POUCH1 pouch2016-09-220000-00-00NoNoCurrent