Diphenhydramine HCl
- Product NDC
- 60687-830
- 11-digit product format
- 606870830
- Labeler code
- 60687
- Product ID
- 60687-830_1c81b131-ccf6-49a7-e063-6394a90a9695
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-08-04
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 25 mg/10mL
- 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
- Diphenhydramine HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/10mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1049906 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b94feeb6-f33f-410d-a9b0-776b1ccf34a9 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60687-830-08 | Diphenhydramine HCl | 3 in 1 CASE | SOLUTION | 3 | 1 | |
| 60687-830-42 | Diphenhydramine HCl | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | 1 | |
| 60687-830-48 | Diphenhydramine HCl | 10 in 1 TRAY | SOLUTION | 10 | 1 | |
| 60687-830-56 | Diphenhydramine HCl | 10 in 1 CASE | SOLUTION | 10 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60687-830-08 | ML - Milliliter | 60687-830 | 74bb08dd-ec95-4d39-844d-b922a7ef398d | 1 | 2024-08-12 |
| 60687-830-42 | ML - Milliliter | 60687-830 | 232e4cae-e85d-4615-bb8a-a476310e3203 | 1 | 2024-08-12 |
| 60687-830-56 | ML - Milliliter | 60687-830 | 62c97559-f178-49b1-a955-80145c3413d1 | 1 | 2024-08-12 |
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 |
|---|---|---|---|---|---|---|
| Mucus Relief DM | DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG | Pioneer Life Sciences, LLC | 3ce0f096-906e-47eb-8061-0ac1e9d8ea55 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 1194c338-e115-4105-93d8-9ab833c43193 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 9c9e558d-d991-4a2e-aa13-37c0b08071e6 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 1695e7ea-2f83-4d3a-980e-c91be6c1f2a5 | 2025-12-25 | Warnings | M012 |
| GUAIFENESIN | GUAIFENESIN | Pharbest Pharmaceuticals, Inc. | 0bf70fb4-d3c8-476d-b864-4eadc697a7d8 | 2025-12-24 | Warnings | M012 |
| PHARBINEX-DM | GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG | Pharbest Pharmaceuticals, Inc. | 8d71db43-da87-45ee-aa4a-7e870bc5016d | 2025-12-24 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Safeway, Inc. | 764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be | 2025-12-23 | Warnings | M012 |
| Tussin | GUAIFENESIN | Discount Drug Mart | 14de3d6d-4eb0-42cf-8941-cb42b3dd5c71 | 2025-12-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | c8dcba06-a461-4af5-a120-666a63f06ac4 | 2025-12-23 | Warnings | M012 |
| SAFETUSSIN MAX STRENGTH MS Cough, Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | KRAMER LABORATORIES | 920bde5f-4079-45de-aa59-24b00e50cb56 | 2025-12-23 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd | 46996bbf-948c-0aba-e063-6394a90a09e3 | 2025-12-23 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc. | 1d2e2a5a-099b-41b3-82bd-5bf704377f78 | 2025-12-23 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 5b493ed7-9044-4841-9935-236d0bdc71a9 | 2025-12-23 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 77a7ff9a-a414-4053-8d8d-369907d4380d | 2025-12-23 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc. | 8f320235-f243-4211-b99c-18526e686548 | 2025-12-23 | Warnings | M012 |
| Circle K Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | b6a46498-d9a8-4da2-9283-57d135f305a5 | 2025-12-23 | Warnings | M012 |
| Circle K Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc. | 7c5faec2-28c6-4c15-a268-d8b578140b74 | 2025-12-23 | Warnings | M012 |
| Sugar Free Honey Lemon Cough Drops | MENTHOL | Walmart | 67650b94-adbb-87fb-e053-2a91aa0a87e6 | 2025-12-23 | Warnings | M012 |
| Equate Benz-Dex Cough and Throat Lozenges | BENZOCAINE | Walmart | c0a6cb7f-a247-e610-e053-2a95a90a4199 | 2025-12-23 | Warnings | M012 |
| Equate Honey Lemon Cough Drops | MENTHOL | WalMart | 0028be18-5162-ff51-e063-6294a90ae517 | 2025-12-23 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | b94feeb6-f33f-410d-a9b0-776b1ccf34a9 | 1 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | b94feeb6-f33f-410d-a9b0-776b1ccf34a9 | 1 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | b94feeb6-f33f-410d-a9b0-776b1ccf34a9 | 1 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | b94feeb6-f33f-410d-a9b0-776b1ccf34a9 | 1 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | b94feeb6-f33f-410d-a9b0-776b1ccf34a9 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60687-830-08 | 60687083008 | 3 TRAY in 1 CASE (60687-830-08) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-830-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-830-42) | 3 tray | 2024-08-04 | No | No | Current |
| 60687-830-42 | 60687083042 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | Historical | |||
| 60687-830-48 | 60687083048 | 10 in 1 TRAY | Historical | ||||
| 60687-830-56 | 60687083056 | 10 TRAY in 1 CASE (60687-830-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-830-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-830-42) | 10 tray | 2024-08-04 | No | No | Current |