Diphenhydramine HCl Oral Solution
- Product NDC
- 69339-151
- 11-digit product format
- 693390151
- Labeler code
- 69339
- Product ID
- 69339-151_6c998d25-3573-4c6b-822a-1c16eeddd642
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diphenhydramine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Natco Pharma USA LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-12-14
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 12.5 mg/5mL
- 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 Oral Solution
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 12.5 mg/5mL |
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 |
|---|---|
| 54b64354-ac10-42ff-a53d-96cef933a91a | 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 |
|---|---|---|---|---|---|---|
| 69339-151-05 | Diphenhydramine HCl Oral Solution | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | 6 | |
| 69339-151-17 | Diphenhydramine HCl Oral Solution | 4 in 1 CASE | SOLUTION | 4 | 6 | |
| 69339-151-17 | Diphenhydramine HCl Oral Solution | 10 in 1 TRAY | SOLUTION | 10 | 6 | |
| 69339-151-19 | Diphenhydramine HCl Oral Solution | 10 in 1 TRAY | SOLUTION | 10 | 6 | |
| 69339-151-19 | Diphenhydramine HCl Oral Solution | 10 in 1 CASE | SOLUTION | 10 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69339-151-05 | ML - Milliliter | 69339-151 | 6b763098-36a9-428b-b99e-2f9d64fd1606 | 1 | 2021-01-08 |
| 69339-151-17 | ML - Milliliter | 69339-151 | 84df1a81-2861-40c1-918e-dbfe443440d7 | 1 | 2021-01-08 |
| 69339-151-19 | ML - Milliliter | 69339-151 | 7ac1751c-0a0c-445d-8889-fbb8b51703b9 | 1 | 2021-01-08 |
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 |
|---|---|---|---|---|---|---|
| Kids Allergy | DIPHENHYDRAMINE HCL | Genexa Inc. | a7bc5f7c-eaeb-25d0-e053-2a95a90a9ec4 | 2026-05-08 | Warnings | M012 |
| day time non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Publix Super Markets Inc | f4fd597f-bca2-4ed4-b353-6c734f2f885c | 2026-05-08 | Warnings | M012 |
| Daytime Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS Pharmacy | d8339bb0-5da3-4f34-a819-339643cf4a97 | 2026-05-08 | Warnings | M012 |
| severe tussin cf | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | a26afc33-533e-4dc0-ab25-21be87356e22 | 2026-05-08 | Warnings | M012 |
| SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | cdd53eba-1fa2-49c1-b03d-c32f309da7fb | 2026-05-08 | Warnings | M012 |
| Benadryl Allergy Liqui-Gels | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | bfeae100-e2d1-4607-be3b-2d9b15cd4f7f | 2026-05-07 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | H E B | 6503761f-37ae-4f39-b727-cb75d4c4a3c9 | 2026-05-07 | Warnings, Adverse reactions | M012 |
| Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TOPCO ASSOCIATES LLC | ad199488-a4be-4b6e-b806-67ce8a6e907e | 2026-05-07 | Warnings | M012 |
| good sense nasal | OXYMETAZOLINE HCL | L. Perrigo Company | 5d42adb9-3625-4072-a6b1-29a229f255c8 | 2026-05-07 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 4856cd7b-ccdf-4546-9c65-236ebaac3dca | 2026-05-06 | Warnings | M012 |
| Mucus Relief All in One Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 0f8928a1-97ef-4128-b8d2-20bdb6e5b6ac | 2026-05-06 | Warnings | M012 |
| daytime cough and chest congestion dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 175cc2d0-0202-4e38-8af2-9fc126b7412d | 2026-05-06 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | HHH Pharmaceuticals | 90fae0fa-da07-4ea8-bdbd-39c2ed99ae59 | 2026-05-06 | Warnings | M012 |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | HHH Pharmaceuticals | 5d8b980f-0011-41e3-a881-ad10fe399079 | 2026-05-06 | Warnings | M012 |
| HALLS Mentholyptus | MENTHOL | Mondelez Global LLC | 38d12374-e2c7-444c-e063-6294a90a42b3 | 2026-05-06 | Warnings | M012 |
| HALLS Mentholyptus | MENTHOL | Mondelez Global LLC | 1ab295ff-94b1-c938-e063-6294a90a98fd | 2026-05-06 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 512af63d-2f09-4baa-e063-6394a90a86bd | 2026-05-06 | Warnings | M012 |
| Thieves Chest Rub | CHEST RUB | Young Living Essential Oils, LC. | 9b7f125e-6caa-c53e-e053-2a95a90a737e | 2026-05-06 | Warnings | M012 |
| Maximum Strength Mucus Relief Plus Pain and Headache | ACETAMINOPHEN, GUAIFENESIN | Shield Pharmaceuticals Corp | f20c0db1-dcf3-4bfc-b3e4-930398f82dc9 | 2026-05-06 | Warnings | M012 |
| Nitetime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Publix Super Markets Inc | 8aa6492b-1723-4c6b-82ee-4f800301c6ad | 2026-05-06 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | 54b64354-ac10-42ff-a53d-96cef933a91a | 6 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | 54b64354-ac10-42ff-a53d-96cef933a91a | 6 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | 54b64354-ac10-42ff-a53d-96cef933a91a | 6 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | 54b64354-ac10-42ff-a53d-96cef933a91a | 6 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | 54b64354-ac10-42ff-a53d-96cef933a91a | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69339-151-05 | 69339015105 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | Historical | ||||
| 69339-151-17 | 69339015117 | 4 TRAY in 1 CASE (69339-151-17) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (69339-151-05) | 4 tray | 2020-12-14 | 0000-00-00 | No | No | Current |
| 69339-151-19 | 69339015119 | 10 TRAY in 1 CASE (69339-151-19) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (69339-151-05) | 10 tray | 2020-12-14 | 0000-00-00 | No | No | Current |