FDA.reportPublic FDA data

Sleep Aid

Product NDC
69168-263
11-digit product format
691680263
Labeler code
69168
Product ID
69168-263_b9e7a97b-a3e9-427c-8cc5-9c94941409a1
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl 25 mg
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-03
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
Sleep Aid
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
dbbc535f-515a-4d9b-b799-34e60f5230bbAvailable 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
69168-263-302020-03-13Drug Facts
69168-263-932020-03-13Drug Facts
69168-263-302020-01-31Drug Facts
69168-263-932020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-263-30Sleep Aid30 in 1 BOTTLETABLET307
69168-263-54Sleep Aid1 in 1 CARTONTABLET17
69168-263-54Sleep Aid16458 in 1 BAGTABLET164587
69168-263-93Sleep Aid24 in 1 BOXTABLET247
69168-263-98Sleep Aid200 in 1 BOTTLETABLET2007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MSLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-263SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]7Current NDC, Legacy NDC, 5 package rows20250515_dbbc535f-515a-4d9b-b799-34e60f5230bb.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 100 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rompe Pecho CFBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDextrum Laboratories, Inc401a97af-36ae-4e54-e063-6294a90ab3ee2025-10-01WarningsExact identifier
application number: M012
NyQuil Severe plus Vicks VapoCool Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Company724d0889-5ba5-3125-e053-2a91aa0a92c12025-10-01WarningsExact identifier
application number: M012
DayQuil Severe plus Vicks VapoCool Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company724f2833-34bd-6a9e-e053-2991aa0a073d2025-10-01WarningsExact identifier
application number: M012
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEInvaTech Pharma Solutions LLCb8d360fa-0d80-f6a8-e053-2a95a90a8bd42025-10-01Exact identifier
application number: M012
LEADER TUSSIN CFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCardinal Health 110, LLC. dba Leaderf4ffe87b-0a62-44ac-b84a-08cf77cda7f52025-10-01WarningsExact identifier
application number: M012
Nasal Spray, 1oz, 24/7 Life by 7-ElevenOXYMETAZOLINE HCL NASAL SOLUTION 0.05%Lil' Drug Store Products, Inc.3e781417-9ffc-f2c9-e063-6294a90a72052025-09-30WarningsExact identifier
application number: M012
Original Extra Strong All Natural Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf2025-09-30WarningsExact identifier
application number: M012
Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3ff240ba-90b2-4c17-e063-6394a90ac56f2025-09-29WarningsExact identifier
application number: M012
DometussCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDextrum Laboratories, Inc3fcace53-a81f-e774-e063-6294a90a32fa2025-09-27WarningsExact identifier
application number: M012
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Incf6a3680a-3ac6-4fd4-be52-ce29064c4aa12025-09-26WarningsExact identifier
application number: M012
No Drip Severe Nasal MistOXYMETAZOLINE SPRAYCVS Health9d9f6c03-0ae1-4f3b-80cd-b23b7c4bdae52025-09-26WarningsExact identifier
application number: M012
Giltuss Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa0b3be-2124-ed1d-e063-6294a90aaf482025-09-25WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey HerbMENTHOLMedical Group Care LLC3fa17255-514f-db47-e063-6294a90ae4542025-09-25WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.3fa17272-fd7f-9ab4-e063-6394a90a585f2025-09-25WarningsExact identifier
application number: M012
MGC Health Throat Soothing Drops Creamy StrawberryPECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.3fa2e438-2ff3-a2df-e063-6394a90ac7b52025-09-25WarningsExact identifier
application number: M012
QUALITY CHOICE ADULT TUSSIN EXPECTORANTGUAIFENESINQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)63dad603-fe2f-42a6-a626-5c8048a42c102025-09-25WarningsExact identifier
application number: M012
Giltuss Childrens Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa5220f-38bb-9ef6-e063-6294a90aeff82025-09-25WarningsExact identifier
application number: M012
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHealth Pharma USA LLCa03befb4-d86d-43e4-8097-eda5c8bb25be2025-09-24WarningsExact identifier
application number: M012
Childrens Giltuss EX ExpectorantGUAIFENESINDextrum Laboratories Inc.3f8d7d47-f14c-888c-e063-6394a90a5cdd2025-09-24WarningsExact identifier
application number: M012
Childrens Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3f909bc2-eb84-a19d-e063-6294a90ae04e2025-09-24WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNdbbc535f-515a-4d9b-b799-34e60f5230bb7
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDdbbc535f-515a-4d9b-b799-34e60f5230bb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-263-306916802633030 TABLET in 1 BOTTLE (69168-263-30) 30 tablet2015-03-030000-00-00NoNoCurrent
69168-263-54691680263541 BAG in 1 CARTON (69168-263-54) / 16458 TABLET in 1 BAG1 bag2025-05-08NoNoCurrent
69168-263-936916802639324 TABLET in 1 BOX (69168-263-93) 24 tablet2015-03-030000-00-00NoNoCurrent
69168-263-9869168026398200 TABLET in 1 BOTTLE (69168-263-98) 200 tablet2021-07-230000-00-00NoNoCurrent