Natureplex Hydrocortisone

Product NDC: 67234-010
11-digit product format: 672340010
Labeler code: 67234
Product ID: 67234-010_c04d26f2-8870-4d41-91a9-519c349b517a
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Natureplex, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-01-22
Substance: HYDROCORTISONE
Active strength: .01 g/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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: Natureplex Hydrocortisone
Brand name suffix: Hydro
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	.01 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WI4X0X7BPJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
106258	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
2fc6a148-34bb-4289-8588-32c1bb011b98	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67234-010-01	Natureplex HydrocortisoneHydro	28 g in 1 TUBE	CREAM	28	16
67234-010-02	Natureplex HydrocortisoneHydro	42.5 g in 1 TUBE	CREAM	42.5	16
67234-010-02	Natureplex HydrocortisoneHydro	1 in 1 CARTON	CREAM	1	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67234-010-01	GM - Gram	67234-010	c4e34dac-eadb-4f14-8d58-68c39ddb36bd	1	2024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hydrocortisone	ACTIVE INGREDIENT	WI4X0X7BPJ	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	12
Hydrocortisone	ACTIVE MOIETY	WI4X0X7BPJ	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	12
alcohol	INACTIVE INGREDIENT	3K9958V90M	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	12
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	12
carbomer homopolymer type C	INACTIVE INGREDIENT	4Q93RCW27E	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	12
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	12
DMDM Hydantoin	INACTIVE INGREDIENT	BYR0546TOW	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	12
edetate trisodium	INACTIVE INGREDIENT	420IP921MB	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	12
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	12
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	12
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	12
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	12
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	12
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	12
trolamine	INACTIVE INGREDIENT	9O3K93S3TK	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	12
water	INACTIVE INGREDIENT	059QF0KO0R	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67234-010	NATUREPLEX HYDROCORTISONE HYDRO (HYDROCORTISONE) CREAM [NATUREPLEX, LLC]	14	Current NDC, Legacy NDC, 3 package rows	20250101_2fc6a148-34bb-4289-8588-32c1bb011b98.zip

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 129 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fruit of the Earth Aloe Vera Cool Blue	LIDOCAINE HYDROCHLORIDE	Fruit of the Earth, Inc.	1d65bc34-2bc2-4f52-a9b3-1cb08324eb79	2024-07-19	Warnings	Exact identifier application number: M017
Ultra Balm	MENTHOL AND METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	de997baf-aa04-474e-b912-3fc67e720d0b	2024-07-19	Warnings	Exact identifier application number: M017
Ling Nam Hak Kwai Oil	TURPENTINE OIL	Ling Nam Medicine Factory (H.K.) Ltd.	3f16cce3-366f-41f3-8829-6de4082a8c19	2024-07-19	Warnings	Exact identifier application number: M017
Koong Yick Hak Kwai Oil	TURPENTINE OIL	Ling Nam Medicine Factory (H.K.) Ltd.	bc33e185-3b42-98b5-e053-2995a90a6308	2024-07-18	Warnings	Exact identifier application number: M017
Koong Yick Hung Fa	METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	9c8a121d-6da2-4435-a2d7-a0b71d10740d	2024-07-18	Warnings	Exact identifier application number: M017
Ling Nam Hung Far	METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	b6916b6e-b7eb-1eb7-e053-2995a90ae6fb	2024-07-18	Warnings	Exact identifier application number: M017
itch relief	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Bionpharma Inc.	178ed513-4f22-8f11-e063-6294a90a109b	2024-07-16	Warnings	Exact identifier application number: M017
POWERECT Benzocaine Male Delay Gel	BENZOCAINE	SKINS SEXUAL HEALTH LIMITED	2fafe1f2-a31e-4b2a-bc51-81e16b319c3a	2024-07-16	Warnings	Exact identifier application number: M017
SKINS DELAY Climax Control Benzocaine Gel	BENZOCAINE	SKINS SEXUAL HEALTH LIMITED	53730576-2609-4f28-8bfa-a1ceea698b83	2024-07-16	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray.	PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAY	Shenzhen Sam Technology Co., Ltd.	1d1a0346-3b00-4803-e063-6294a90aec6d	2024-07-13	Warnings	Exact identifier application number: M017
Tidl Pain Relief Evening Therapy Spray.	PAIN RELIEF EVENING THERAPY SPRAY	Shenzhen Sam Technology Co., Ltd.	1d1a2f4a-7b25-e595-e063-6394a90a00d5	2024-07-13	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF HEAT THERAPY ROLL-ON	PAIN RELIEF HEAT THERAPY ROLL-ON	Shenzhen Sam Technology Co., Ltd.	1d0b7b8f-9e5d-00f7-e063-6394a90af87c	2024-07-12	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY original formula Spray.	PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAY	Shenzhen Sam Technology Co., Ltd.	1d0b94ec-f956-dff2-e063-6294a90aca4a	2024-07-12	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray.	PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAY	Shenzhen Sam Technology Co., Ltd.	1d0bf4f9-6b02-6cec-e063-6294a90a36c7	2024-07-12	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE HCI 2.0%	Trifecta Pharmaceuticals USA, LLC.	e5e524cd-bb22-715f-e053-2995a90ab5d3	2024-07-12	Warnings	Exact identifier application number: M017
Ralli Rapid Pain Relief	MENTHOL	Troy Manufacturing, Inc.	1d10e3ca-dc93-8e1a-e063-6394a90a47c0	2024-07-12	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF HEAT THERAPY Spray.	PAIN RELIEF HEAT THERAPY SPRAY	Shenzhen Sam Technology Co., Ltd.	1d199826-1b27-b6e7-e063-6394a90a69ad	2024-07-12	Warnings	Exact identifier application number: M017
Tidl Pain Relief Morning Therapy Spray.	PAIN RELIEF MORNING THERAPY SPRAY	Shenzhen Sam Technology Co., Ltd.	1d19d070-3818-73de-e063-6394a90a8958	2024-07-12	Warnings	Exact identifier application number: M017
Hydrocortisone with aloe	HYDROCORTISONE WITH ALOE ANTI ITCH	NeilMed Pharmaceuticals Inc.	032b9f58-5f64-04dd-e063-6294a90a6bb9	2024-07-10	Warnings	Exact identifier application number: M017
Octagon Pain Relief	MENTHOL, UNSPECIFIED FORM	NATURAL ESSENTIALS, INC.	9926f733-1506-4224-9d70-b1813cd81ec3	2024-07-08	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
106258	hydrocortisone 1 % Topical Cream	PSN	2fc6a148-34bb-4289-8588-32c1bb011b98	16
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	2fc6a148-34bb-4289-8588-32c1bb011b98	16
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	2fc6a148-34bb-4289-8588-32c1bb011b98	16
106258	hydrocortisone 1 % Topical Cream	SY	2fc6a148-34bb-4289-8588-32c1bb011b98	16
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	2fc6a148-34bb-4289-8588-32c1bb011b98	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67234-010-01	67234001001	28 g in 1 TUBE (67234-010-01)	28 g	2008-01-22	0000-00-00	No	No	Current
67234-010-02	67234001002	1 TUBE in 1 CARTON (67234-010-02) / 42.5 g in 1 TUBE	1 tube	2022-12-09		No	No	Current