FDA.reportPublic FDA data

Diphenhydramine HCL

Product NDC
66267-080
11-digit product format
662670080
Labeler code
66267
Product ID
66267-080_e767c105-d9e1-7162-e053-2a95a90afc9d
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-01-27
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66267-080-152025-01-30C16284748780-12cef2736-a88f-d83d-e063-dadaa90ab31fDrug Facts
66267-080-202025-01-30C16284748780-12cef2736-a88f-d83d-e063-dadaa90ab31fDrug Facts
66267-080-242025-01-30C16284748780-12cef2736-a88f-d83d-e063-dadaa90ab31fDrug Facts
66267-080-302025-01-30C16284748780-12cef2736-a88f-d83d-e063-dadaa90ab31fDrug Facts
66267-080-602025-01-30C16284748780-12cef2736-a88f-d83d-e063-dadaa90ab31fDrug Facts
66267-080-902025-01-30C16284748780-12cef2736-a88f-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-080-15Diphenhydramine HCL15 in 1 BOTTLE, PLASTICCAPSULE155
66267-080-20Diphenhydramine HCL20 in 1 BOTTLE, PLASTICCAPSULE205
66267-080-24Diphenhydramine HCL24 in 1 BOTTLE, PLASTICCAPSULE245
66267-080-30Diphenhydramine HCL30 in 1 BOTTLE, PLASTICCAPSULE305
66267-080-60Diphenhydramine HCL60 in 1 BOTTLE, PLASTICCAPSULE605
66267-080-90Diphenhydramine HCL90 in 1 BOTTLE, PLASTICCAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-080-15EA - Each66267-0808e70239c-bd12-412b-95d5-3b52430e878f12016-10-06
66267-080-20EA - Each66267-08007bdd1aa-f4ce-4065-93e2-33a7106edff412016-10-06
66267-080-30EA - Each66267-080a745398b-7212-4a02-887a-a7abfd43b64f12016-10-06
66267-080-60EA - Each66267-08062c9460b-d856-4ddf-8be7-0b8a279afa3212016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-080DIPHENHYDRAMINE HCL CAPSULE [NUCARE PHARMACEUTICALS, INC.]5Legacy NDC, 6 package rows20220831_3dbdf67f-766b-12ee-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN3dbdf67f-766b-12ee-e054-00144ff8d46c5
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD3dbdf67f-766b-12ee-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-080-156626700801515 CAPSULE in 1 BOTTLE, PLASTIC (66267-080-15) 15 capsule2016-09-300000-00-00NoNoCurrent
66267-080-206626700802020 CAPSULE in 1 BOTTLE, PLASTIC (66267-080-20) 20 capsule2016-09-300000-00-00NoNoCurrent
66267-080-246626700802424 CAPSULE in 1 BOTTLE, PLASTIC (66267-080-24) 24 capsule2016-09-300000-00-00NoNoCurrent
66267-080-306626700803030 CAPSULE in 1 BOTTLE, PLASTIC (66267-080-30) 30 capsule2016-09-300000-00-00NoNoCurrent
66267-080-606626700806060 CAPSULE in 1 BOTTLE, PLASTIC (66267-080-60) 60 capsule2016-09-300000-00-00NoNoCurrent
66267-080-906626700809090 CAPSULE in 1 BOTTLE, PLASTIC (66267-080-90) 90 capsule2016-09-300000-00-00NoNoCurrent