Diphenhydramine HCL
- Product NDC
- 66424-021
- 11-digit product format
- 664240021
- Labeler code
- 66424
- Product ID
- 66424-021_2ba30474-41ba-6c1a-e063-6394a90a9631
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCL
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- SDA Laboratories, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2010-01-27
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 50 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
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 66424-021-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 66424-021-01 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 66424-021-10 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 66424-021-01 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 66424-021-10 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 66424-021-01 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 66424-021-10 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 66424-021-01 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 66424-021-10 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 66424-021-01 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 66424-021-10 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 66424-021-01 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 66424-021-10 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 66424-021-01 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 66424-021-10 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 66424-021-01 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
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 HCL
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1020477 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 437e6a13-a4ff-4f98-8973-042f224ee85e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 66424-021-01 | 2023-06-13 | Drug Facts |
| 66424-021-10 | 2023-06-13 | Drug Facts |
| 66424-021-01 | 2020-01-31 | Drug Facts |
| 66424-021-10 | 2020-01-31 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66424-021-01 | Diphenhydramine HCL | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | 3 | |
| 66424-021-10 | Diphenhydramine HCL | 1000 in 1 BOTTLE, PLASTIC | CAPSULE | 1000 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66424-021-01 | EA - Each | 66424-021 | 9776653f-7c63-4b8b-a643-b1ff64504064 | 1 | 2012-07-24 |
| 66424-021-10 | EA - Each | 66424-021 | fa4dd348-3929-4217-a7fb-c7f312f780c8 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | bab078bb-f6b0-4394-84de-92b2c582b5da | 2026-01-12 | Warnings | M012 |
| Nasal Decongestant PE Non-Drowsy Maximum Strength | PHENYLEPHRINE HCL | CHAIN DRUG MARKETING ASSOCIATION INC | bf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d | 2026-01-12 | Warnings | M012 |
| CVS Health Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | CVS Pharmacy | 022c3083-c611-47d0-aa93-d6c7612e7a47 | 2026-01-11 | Warnings | M012 |
| CVS Health Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | CVS Pharmacy | bf73d15a-9d68-42fa-bfee-d25748215f97 | 2026-01-11 | Warnings | M012 |
| GUAIFENESIN 400MG CAPLETS | GUAIFENESIN | Gendose Pharmaceuticals, LLC | e7b82ec7-ef23-50c1-e053-2a95a90a662f | 2026-01-10 | Warnings | M012 |
| Daytime Cold and Flu | DAYTIME COLD AND FLU | Allegiant Health | 69ed2da0-16b2-49eb-91b4-cc5cf328c817 | 2026-01-09 | Warnings | M012 |
| HyVee Cough Drops Original Herb | MENTHOL | HY-VEE, INC | 47f81e54-0ce4-439d-e063-6294a90a2abe | 2026-01-09 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | A-S Medication Solutions | a5809774-ed52-4f54-b48e-888631e0223d | 2026-01-09 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | A-S Medication Solutions | 5767f546-a751-4583-a8b7-971175c27ef0 | 2026-01-09 | Warnings | M012 |
| Thompson Cough and Cold Multi-Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE, GUAIFENESIN, , | Thompson | e77725b1-15da-35bd-e053-2a95a90ad6ba | 2026-01-08 | Warnings | M012 |
| Mucosan Childrens Multi-Symptom Grape | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Menper Distributors, Inc. | 266c8cce-cdf9-557d-e063-6394a90a9bc3 | 2026-01-08 | Warnings | M012 |
| Mucosan Multi-Symptom Honey | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Menper Distributors, Inc. | 2669c620-ab70-abaa-e063-6394a90a58e7 | 2026-01-08 | Warnings | M012 |
| Mucosan Multi-Symptom Cherry | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Menper Distributors, Inc. | 26b8c06d-4a72-3979-e063-6394a90a96d7 | 2026-01-08 | Warnings | M012 |
| Mucosan Max with Acetaminophen | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE | Menper Distributors, Inc. | 26a4861b-5d8e-9ec6-e063-6394a90af577 | 2026-01-08 | Warnings | M012 |
| Mucosan Severe Multi-Symptom | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Menper Distributors, Inc. | 26a69342-f65f-cb46-e063-6394a90ade10 | 2026-01-08 | Warnings | M012 |
| HyVee Cough Drops Original Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | e4e15c13-f583-4484-a5f0-f04c39c7b7c9 | 2026-01-08 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy | ASPRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | a355d987-77ce-9e32-e053-2995a90a6431 | 2026-01-08 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | e07931fc-f753-1aeb-e053-2a95a90ada3f | 2026-01-08 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | fc60af2f-83cb-99ea-e053-6394a90a0b3b | 2026-01-08 | Warnings | M012 |
| Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | e17eb929-209d-a2d1-e053-2a95a90a4cf3 | 2026-01-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049909 | diphenhydrAMINE HCl 25 MG Oral Capsule | PSN | 3ac0beba-303d-404e-bfec-0cf8c0e8624d | 12 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 3ac0beba-303d-404e-bfec-0cf8c0e8624d | 12 |
| 1049909 | diphenhydramine hydrochloride 25 MG Oral Capsule | SCD | 3ac0beba-303d-404e-bfec-0cf8c0e8624d | 12 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 3ac0beba-303d-404e-bfec-0cf8c0e8624d | 12 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 3ac0beba-303d-404e-bfec-0cf8c0e8624d | 12 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | c1873a4c-661f-4896-bcc0-f6d3a655de94 | 5 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 6e91b9c3-57e8-488b-ac70-d863cdf9d6e8 | 5 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | c1873a4c-661f-4896-bcc0-f6d3a655de94 | 5 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 6e91b9c3-57e8-488b-ac70-d863cdf9d6e8 | 5 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | c1873a4c-661f-4896-bcc0-f6d3a655de94 | 5 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 6e91b9c3-57e8-488b-ac70-d863cdf9d6e8 | 5 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 3dbdf020-ca17-1197-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 489645ad-d7da-5f52-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 489645ad-d7da-5f52-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 3dbdf020-ca17-1197-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 489645ad-d7da-5f52-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 3dbdf020-ca17-1197-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 437e6a13-a4ff-4f98-8973-042f224ee85e | 3 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 437e6a13-a4ff-4f98-8973-042f224ee85e | 3 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 437e6a13-a4ff-4f98-8973-042f224ee85e | 3 |
| 1049909 | diphenhydrAMINE HCl 25 MG Oral Capsule | PSN | c46e1443-dffe-47a9-bc9a-acbe3a8b0b41 | 1 |
| 1049909 | diphenhydramine hydrochloride 25 MG Oral Capsule | SCD | c46e1443-dffe-47a9-bc9a-acbe3a8b0b41 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 66424-021-01 | 66424002101 | 100 CAPSULE in 1 BOTTLE, PLASTIC (66424-021-01) | 100 capsule | 2010-01-27 | No | No | Current |
| 66424-021-10 | 66424002110 | 1000 CAPSULE in 1 BOTTLE, PLASTIC (66424-021-10) | 1000 capsule | 2010-01-27 | No | No | Current |