FDA.reportPublic FDA data

Calmco

Product NDC
73282-2525
11-digit product format
732822525
Labeler code
73282
Product ID
73282-2525_4e58cc8b-5c0c-8da6-e063-6394a90a13a0
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
CalmCo LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/5mL
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
Calmco
Brand name suffix
Sleep Aid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
471d4c70-813a-19de-e063-6394a90aeb25Available 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
73282-2525-1CalmcoSleep Aid10 mL in 1 VIAL, SINGLE-DOSESOLUTION101
73282-2525-2CalmcoSleep Aid18 in 1 POUCHSOLUTION181

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 8 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dg health sleep aidDIPHENHYDRAMINE HCLDolgencorp, LLC4c266acb-49ae-4d04-8602-0df35b22874a2025-07-10WarningsExact identifier
application number: M010
NIGHT TIME SLEEP-AIDDIPHENHYDRAMINE HCLAdvanced Rx LLC07c69e63-deb1-4607-9f7f-1cf0cd05cc822025-07-02WarningsExact identifier
application number: M010
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDEDISCOUNT DRUG MART896ae7b8-cb8d-1aaa-e053-2a95a90a4e1a2025-06-30WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)027d7eff-6c83-40f1-9716-231637cdbeba2025-06-12WarningsExact identifier
application number: M010
Nighttime Sleep Aid maximum strengthDIPHENHYDRAMINE HCLCardinal Health (Leader) 70000546e4fda-6eb2-4358-840e-e2473bf7f3522025-06-03WarningsExact identifier
application number: M010
Simply SleepDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC37c606b0-04d5-49f0-886a-3ee2c9b0e9cc2025-06-02WarningsExact identifier
application number: M010
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLWinCo Foods, LLCe9bc5a16-b1fc-4585-8f3b-30ccf43004922025-05-30WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLCare One (Retail Business Services, LLC.)51e633a8-5bfc-4ff9-816f-3bc22b8a5c4c2025-05-23WarningsExact identifier
application number: M010
Nighttime Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLCare One (Retail Business Services, LLC.)536cd7d6-a470-4614-89c8-6c3ada582a902025-05-23WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLCardinal Health (Leader) 70000133d6f38-9de7-4104-8175-3933b263afe02025-05-16WarningsExact identifier
application number: M010
Nighttime Sleep-aidDIPHENHYDRAMINE HCLNORTHEAST PHARMAd2062094-d1b5-38ab-e053-2995a90a56702025-05-15WarningsExact identifier
application number: M010
Nighttime Sleep-aidDIPHENHYDRAMINE HCLGeri-Care Pharmaceutical Corp0fce381f-28ef-4591-a569-c5d599a3b95f2025-05-14WarningsExact identifier
application number: M010
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association54bdb6bc-622c-412a-8365-a1b1c968e13e2025-05-01WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI217a211e-b8bf-4119-a094-0e5e733d0b182025-04-21WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)25f32a1c-0687-45e9-8142-96cf635990902025-04-03WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLFSA Store Inc. (Caring Mills)9d32a3a1-9528-4de4-9fd1-1d01a1ad93e92025-03-28WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLWR Group, Inc.d28d0f6d-8029-4e31-b417-4f8f864d840e2025-03-28WarningsExact identifier
application number: M010
Sleep Aid NightTimeDIPHENHYDRAMINE HCLP & L Development, LLC4144b1a6-aeae-4560-a997-b07206d803502025-03-24WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLStrategic Sourcing Services LLCa512413c-639b-4846-b016-332a78b50ab72025-03-21WarningsExact identifier
application number: M010
Diphenhydramine HClDIPHENHYDRAMINE HCLPD-Rx Pharmaceuticals, Inc.1ee41c86-6767-43ca-a5bb-fc685fa662cd2025-03-20WarningsExact identifier
application number: M010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73282-2525-17328225250110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
73282-2525-27328225250218 VIAL, SINGLE-DOSE in 1 POUCH (73282-2525-2) / 10 mL in 1 VIAL, SINGLE-DOSE (73282-2525-1) 2026-01-01NoNoCurrent